Publications

  • Source

    Full-text · Article · Nov 2015 · Trials
  • [Show abstract] [Hide abstract]
    ABSTRACT: Cutaneous leishmaniasis (CL) is endemic in the northern region of Guatemala reporting a prevalence of less than 1%. The National Ministry of Health (NMH) recognizes the challenges in underreporting and limitations in the care of patients, and has taken steps to improve surveillance by moving from a passive to active monitoring system in the last five years. We evaluated the national CL system documenting the obstacles and identifying opportunities toward improving diagnosis and treatment. This cross sectional study, performed in collaboration with the NMH aimed to: a) estimate the prevalence of CL in communities with the highest reports in 2014 in the department of Alta Verapáz, b) estimate the proportion of patients with suspected CL utilizing health services, c) assess the knowledge, attitudes and practices of CL in the affected population, and d) evaluate the meglumine antimoniate supply chain management, distribution and use for CL. The survey included 371 households from 11 communities, where 85 suspected cases of CL were identified from April to June, 2015. Fifty-one cases were evaluated of which 34 (67%) were clinically consistent or microscopically confirmed as CL, resulting in a prevalence estimate of 3.8% (34/673). The majority of the survey respondents recognized the term CL or the CL lesions in photographs, and mentioned a fly as the vector. Sixty seven percent believed that CL affects their lives by limiting their ability to work. Some respondents reported plant preparations and other substances as common treatment for CL lesions. The majority of respondents (63.6%) reported that closer distances to health facilities would facilitate access to NMH treatment. In terms of the drug supply management, the NMH provides and stocks a sufficient amount of meglumine antimoniate in health centers but distribution to patients, dosing and route of administration are inconsistent. Approaches in national surveillance and treatment of CL could improve through enhancing NMH diagnosis capabilities, facilitating local understanding of treatment strategies for CL, developing better drug distribution systems and standardizing dosing and administration of meglumine antimoniate.
    No preview · Conference Paper · Oct 2015
  • Source

    Full-text · Article · Nov 2014 · The Lancet Global Health
  • [Show abstract] [Hide abstract]
    ABSTRACT: Objectives: We identified barriers to care seeking for pneumonia and diarrhea among rural Guatemalan children. Methods: A population-based survey was conducted twice from 2008 to 2009 among 1605 households with children younger than 5 years. A 14-day calendar recorded episodes of carer-reported pneumonia (n = 364) and diarrhea (n = 481), and formal (health services, public, private) and informal (neighbors, traditional, local shops, pharmacies) care seeking. Results: Formal care was sought for nearly half of severe pneumonias but only for 27% within 2 days of onset, with 31% and 18%, respectively, for severe diarrhea. In multivariable analysis, factors independently associated with formal care seeking were knowing the Community Emergency Plan, mother's perception of illness severity, recognition of World Health Organization danger signs, distance from the health center, and having someone to care for family in an emergency. Conclusions: Proximal factors associated with recognizing need for care were important in determining formal care, and were strongly linked to social determinants. In addition to specific action by the health system with an enhanced community health worker role, a systems approach can help ensure barriers are addressed among poorer and more remote homes.
    No preview · Article · Feb 2014 · American Journal of Public Health
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: For the treatment of visceral leishmaniasis in Bangladesh, single dose liposomal amphotericin B (ambisome) is supposed to be the safest and most effective treatment. Specific needs for application and storage raise questions about feasibility of its implementation and acceptance by patients and health staff. Methods. The study was carried out in the most endemic district of Bangladesh. Study population includes patients treated with ambisome or miltefosine, hospital staff, and a director of the national visceral leishmaniasis program. Study methods include direct observation (subdistrict hospitals), open interviews (heath staff and program personnel), structured questionnaires, and focus group discussions (patients). Results. Politicalcommitment for ambisome is strong; the general hospital infrastructure favours implementation but further strengthening is required, particularly for drug storage below 25°C (refrigerators), back-up energy (fuel for generators), and supplies for ambisome administration (like 5% dextrose solution). Ambisome created high satisfaction in patients and hospital staff, less adverse events, and less income loss for patients compared to miltefosine. Conclusions. High political commitment, general capacities of subdistrict hospitals, and high acceptability favour the implementation of ambisome treatment in Bangladesh. However, strengthening of the infrastructure and uninterrupted supplies of essential accessories is mandatory before introducing sLAB in Bangladesh.
    Full-text · Article · Jan 2014 · Journal of Tropical Medicine
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To rapidly reduce the burden of visceral leishmaniasis for national elimination programmes, an acceptable, safe, and effective treatment is needed that can be delivered at primary health-care centres. We aimed to assess the tolerability, safety, and cure rate of single-dose liposomal amphotericin B (AmBisome, Gilead, USA) for visceral leishmaniasis treatment in such a setting in Bangladesh.
    Full-text · Article · Dec 2013 · The Lancet
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The current evidence-base for recommendations on the treatment of cutaneous leishmaniasis (CL) is generally weak. Systematic reviews have pointed to a general lack of standardization of methods for the conduct and analysis of clinical trials of CL, compounded with poor overall quality of several trials. For CL, there is a specific need for methodologies which can be applied generally, while allowing the flexibility needed to cover the diverse forms of the disease. This paper intends to provide clinical investigators with guidance for the design, conduct, analysis and report of clinical trials of treatments for CL, including the definition of measurable, reproducible and clinically-meaningful outcomes. Having unified criteria will help strengthen evidence, optimize investments, and enhance the capacity for high-quality trials. The limited resources available for CL have to be concentrated in clinical studies of excellence that meet international quality standards.
    Full-text · Article · Mar 2013 · PLoS Neglected Tropical Diseases
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background Active case detection (ACD) significantly contributes to early detection and treatment of visceral leishmaniasis (VL) and post kala-azar dermal leishmaniasis (PKDL) cases and is cost effective. This paper evaluates the performance and feasibility of adapting ACD strategies into national programs for VL elimination in Bangladesh, India and Nepal. Methods The camp search and index case search strategies were piloted in 2010-11 by national programs in high and moderate endemic districts / sub-districts respectively. Researchers independently assessed the performance and feasibility of these strategies through direct observation of activities and review of records. Program costs were estimated using an ingredients costing method. Results Altogether 48 camps (Bangladesh-27, India-19, Nepal-2) and 81 index case searches (India-36, Nepal-45) were conducted by the health services across 50 health center areas (Bangladesh-4 Upazillas, India-9 PHCs, Nepal-37 VDCs). The mean number of new case detected per camp was 1.3 and it varied from 0.32 in India to 2.0 in Bangladesh. The cost (excluding training costs) of detecting one new VL case per camp varied from USD 22 in Bangladesh, USD 199 in Nepal to USD 320 in India. The camp search strategy detected a substantive number of new PKDL cases. The major challenges faced by the programs were inadequate preparation, time and resources spent on promoting camp awareness through IEC activities in the community. Incorrectly diagnosed splenic enlargement at camps probably due to poor clinical examination skills resulted in a high proportion of patients being subjected to rK39 testing. Conclusion National programs can adapt ACD strategies for detection of new VL/PKDL cases. However adequate time and resources are required for training, planning and strengthening referral services to overcome challenges faced by the programs in conducting ACD.
    Full-text · Article · Nov 2012 · BMC Public Health
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective: Standard treatment of Indian post-kala-azar dermal leishmaniasis (PKDL) is unsatisfactory because to achieve therapeutic effectiveness, heroic courses of parenteral and toxic agents have to be administered. Our objective was to evaluate oral miltefosine for its potential to provide effective as well as tolerable treatment for this disease. Method: Open-label, randomised, parallel-group multicentric trial. Miltefosine, 100 mg/day to all but one patient, was administered for 12 weeks or 8 weeks, with a target of 18 patients in each treatment group. Key endpoints were tolerance during treatment and efficacy at 12 months of follow-up. Results: The ITT and per-protocol cure rates after 12 months of follow-up for patients receiving 12 weeks of therapy were 78% (14 of 18 patients: 95% CI = 61-88%) and 93% (14 of 15 patients: 95% CI = 71-95%), respectively, after 12 months of follow-up. The ITT and per-protocol cure rates for patients receiving 8 weeks of therapy were 76% (13 of 17 patients: 95% CI = 53-90%) and 81% (13 of 16 patients: 95% CI = 57-93%), respectively. Gastrointestinal and other adverse events were rare. Conclusions: This study suggests that oral miltefosine for 2-3 months can be considered a treatment of choice for Indian PKDL.
    Full-text · Article · Nov 2012 · Tropical Medicine & International Health
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background In view of the epidemiological expansion of dengue worldwide and the availability of new tools and strategies particularly for controlling the primary dengue vector Aedes aegypti, an intervention study was set up to test the efficacy, cost and feasibility of a combined approach of insecticide treated materials (ITMs) alone and in combination with appropriate targeted interventions of the most productive vector breeding-sites. Methods The study was conducted as a cluster randomized community trial using “reduction of the vector population” as the main outcome variable. The trial had two arms: 10 intervention clusters (neighborhoods) and 10 control clusters in the town of Poptun Guatemala. Activities included entomological assessments (characteristics of breeding-sites, pupal productivity, Stegomyia indices) at baseline, 6 weeks after the first intervention (coverage of window and exterior doorways made of PermaNet 2.0 netting, factory treated with deltamethrin at 55 mg/m2, and of 200 L drums with similar treated material) and 6 weeks after the second intervention (combination of treated materials and other suitable interventions targeting productive breeding-sites i.e larviciding with Temephos, elimination etc.). The second intervention took place 17 months after the first intervention. The insecticide residual activity and the insecticidal content were also studied at different intervals. Additionally, information about demographic characteristics, cost of the intervention, coverage of houses protected and satisfaction in the population with the interventions was collected. Results At baseline (during the dry season) a variety of productive container types for Aedes pupae were identified: various container types holding >20 L, 200 L drums, washbasins and buckets (producing 83.7% of all pupae). After covering 100% of windows and exterior doorways and a small number of drums (where the commercial cover could be fixed) in 970 study households, tropical rains occurred in the area and lead to an increase of the vector population, more pronounced (but statistically not significant) in the control arm than in the intervention arm. In the second intervention (17 months later and six weeks after implementing the second intervention) the combined approach of ITMs and a combination of appropriate interventions against productive containers (Temephos in >200 L water drums, elimination of small discarded tins and bottles) lead to significant differences on reductions of the total number of pupae (P = 0.04) and the House index (P = 0.01) between intervention and control clusters, and to borderline differences on reductions of the Pupae per Person and Breteau indices (P = 0.05). The insecticide residual activity on treated curtains was high until month 18 but the chemical concentration showed a high variability. The cost per house protected with treated curtains and drum covers and targeting productive breeding-sites of the dengue vector was $ 5.31 USD. The acceptance of the measure was generally high, particularly in families who had experienced dengue. Conclusion Even under difficult environmental conditions (open houses, tropical rainfall, challenging container types mainly in the peridomestic environment) the combination of insecticide treated curtains and to a less extent drum covers and interventions targeting the productive container types can reduce the dengue vector population significantly.
    Full-text · Article · Oct 2012 · BMC Public Health
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Objectives: To investigate the changes of bacteriological index and leprosy reactions among Multi-bacillary (MB) patients treated with uniform multi-drug therapy (UMDT). Methods: Newly diagnosed leprosy patients were recruited after taking informed consent in three districts in Guizhou Province and one district in Yunnan Province China during November 2003 to June 2005 and were treated with Uniform Multidrug Therapy. All patients were followed up once a year for 3 years after completion of treatment. All data on bacteriological index (BI) and the frequencies of leprosy reaction were collected and analysed. Results: A total of 166 patients were recruited for UMDT trial. Among them 114 patients had positive BI smear, and 83 patients had been followed up for 42 months. The mean BI of 83 patients decreased from 2.84 before treatment to 0.33 at the end of 42 months follow-up. At the end of this period, 61 patients (73.5%) had become BI negative. There were 13 (14.6%) patients who had a Type I reaction during 24 months of follow-up. One patient in the study group relapsed 13 months after stopping treatment of the UMDT. Conclusion: There was a significant decrease in the mean BI and 73.5% of patients treated with UMDT became BI negative during 3 years' follow-up. The frequency of Type I reaction seemed a little higher among patients treated with UMDT, but the numbers of patients enrolled were too few to determine statistical significance. Future studies on U-MDT should also study Type I reactions in these patients.
    Full-text · Article · Jun 2012 · Leprosy review
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: . National VL Elimination Programs in India, Nepal and Bangladesh face challenges as home-based Miltefosine treatment is introduced. Objectives . To study constraints of VL management in endemic districts within context of national elimination programs before and after intervention. Methods . Ninety-two and 41 newly diagnosed VL patients were interviewed for clinical and provider experience in 2009 before and in 2010 after intervention (district training and improved supply of diagnostics and drugs). Providers were assessed for adherence to treatment guidelines. Facilities and doctor-patient consultations were observed to assess quality of care. Results . Miltefosine use increased from 33% to 59% except in Nepal where amphotericin was better available. Incorrect dosage and treatment interruptions were rare. Advice on potential side effects was uncommon but improved significantly in 2010. Physicians did not rule out pregnancy prior to starting Miltefosine. Fever measurement or spleen palpation was infrequently done in Bangladesh but improved after intervention (from 23% to 47%). Physician awareness of renal or liver toxicity as Miltefosine side effects was lower in Bangladesh. Bio-chemical monitoring was uncommon. Patient satisfaction with services remained low for ease of access or time provider spent with patient. Health facilities were better stocked with rK39 kits and Miltefosine in 2010.
    Full-text · Article · May 2012 · Journal of Tropical Medicine
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Pneumonia causes more child deaths than does any other disease. Observational studies have indicated that smoke from household solid fuel is a significant risk factor that affects about half the world's children. We investigated whether an intervention to lower indoor wood smoke emissions would reduce pneumonia in children. We undertook a parallel randomised controlled trial in highland Guatemala, in a population using open indoor wood fires for cooking. We randomly assigned 534 households with a pregnant woman or young infant to receive a woodstove with chimney (n=269) or to remain as controls using open woodfires (n=265), by concealed permuted blocks of ten homes. Fieldworkers visited homes every week until children were aged 18 months to record the child's health status. Sick children with cough and fast breathing, or signs of severe illness were referred to study physicians, masked to intervention status, for clinical examination. The primary outcome was physician-diagnosed pneumonia, without use of a chest radiograph. Analysis was by intention to treat (ITT). Infant 48-h carbon monoxide measurements were used for exposure-response analysis after adjustment for covariates. This trial is registered, number ISRCTN29007941. During 29,125 child-weeks of surveillance of 265 intervention and 253 control children, there were 124 physician-diagnosed pneumonia cases in intervention households and 139 in control households (rate ratio [RR] 0·84, 95% CI 0·63-1·13; p=0·257). After multiple imputation, there were 149 cases in intervention households and 180 in controls (0·78, 0·59-1·06, p=0·095; reduction 22%, 95% CI -6% to 41%). ITT analysis was undertaken for secondary outcomes: all and severe fieldworker-assessed pneumonia; severe (hypoxaemic) physician-diagnosed pneumonia; and radiologically confirmed, RSV-negative, and RSV-positive pneumonia, both total and severe. We recorded significant reductions in the intervention group for three severe outcomes-fieldworker-assessed, physician-diagnosed, and RSV-negative pneumonia--but not for others. We identified no adverse effects from the intervention. The chimney stove reduced exposure by 50% on average (from 2·2 to 1·1 ppm carbon monoxide), but exposure distributions for the two groups overlapped substantially. In exposure-response analysis, a 50% exposure reduction was significantly associated with physician-diagnosed pneumonia (RR 0·82, 0·70-0·98), the greater precision resulting from less exposure misclassification compared with use of stove type alone in ITT analysis. In a population heavily exposed to wood smoke from cooking, a reduction in exposure achieved with chimney stoves did not significantly reduce physician-diagnosed pneumonia for children younger than 18 months. The significant reduction of a third in severe pneumonia, however, if confirmed, could have important implications for reduction of child mortality. The significant exposure-response associations contribute to causal inference and suggest that stove or fuel interventions producing lower average exposures than these chimney stoves might be needed to substantially reduce pneumonia in populations heavily exposed to biomass fuel air pollution. US National Institute of Environmental Health Sciences and WHO.
    Full-text · Article · Nov 2011 · The Lancet
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Miltefosine (target dose of 2.5 mg/kg/day for 28 days) is the recommended treatment for visceral leishmaniasis (kala-azar) in Bangladesh on the basis of data from India. We evaluated miltefosine in a phase IV trial of 977 patients in Bangladesh. At the six-month final follow up, 701 were cured. 24 showed initial treatment failure, and 95 showed treatment failure at 6 months, although 73 of the 95 showed treatment failure solely by the criterion of low hemoglobin values. One hundred twenty-one patients were not assessable. With the conservative assumption that all low hemoglobin values represented treatment failure, the final per protocol cure rate was 85%. Of 13 severe adverse events, 6 led to treatment discontinuation and 7 resulted in deaths, but only 1 death (associated with diarrhea) could be attributed to drug. Nearly all non-serious adverse events were gastrointestinal: vomiting in 25% of patients and diarrhea in 8% of patients. Oral miltefosine is an attractive alternative to intramuscular antimony and intravenous amphotericin B for treatment of kala-azar in Bangladesh.
    Full-text · Article · Jul 2011 · The American journal of tropical medicine and hygiene
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: A large body of evidence suggests that fine particulate matter (PM) air pollution is a cause of cardiovascular disease, but little is known in particular about the cardiovascular effects of indoor air pollution from household use of solid fuels in developing countries. RESPIRE (Randomized Exposure Study of Pollution Indoors and Respiratory Effects) was a randomized trial of a chimney woodstove that reduces wood smoke exposure. We tested the hypotheses that the stove intervention, compared with open fire use, would reduce ST-segment depression and increase heart rate variability (HRV). We used two complementary study designs: a) between-groups comparisons based on randomized stove assignment, and b) before-and-after comparisons within control subjects who used open fires during the trial and received chimney stoves after the trial. Electrocardiogram sessions that lasted 20 hr were repeated up to three times among 49 intervention and 70 control women 38-84 years of age, and 55 control subjects were also assessed after receiving stoves. HRV and ST-segment values were assessed for each 30-min period. ST-segment depression was defined as an average value below -1.00 mm. Personal fine PM [aerodynamic diameter ≤ 2.5 μm (PM₂.₅] exposures were measured for 24 hr before each electrocardiogram. PM₂.₅ exposure means were 266 and 102 μg/m³ during the trial period in the control and intervention groups, respectively. During the trial, the stove intervention was associated with an odds ratio of 0.26 (95% confidence interval, 0.08-0.90) for ST-segment depression. We found similar associations with the before-and-after comparison. The intervention was not significantly associated with HRV. The stove intervention was associated with reduced occurrence of nonspecific ST-segment depression, suggesting that household wood smoke exposures affect ventricular repolarization and potentially cardiovascular health.
    Full-text · Article · Jun 2011 · Environmental Health Perspectives
  • [Show abstract] [Hide abstract]
    ABSTRACT: The world's burden of infectious diseases can be substantially reduced by more-effective use of existing interventions. Advances in case detection, diagnosis, and treatment strategies have made it possible to consider the elimination of visceral leishmaniasis in the Indian subcontinent. The priority must now be to effectively implement existing interventions at the community level by actively finding cases in endemic villages and treating them with single-dose liposomal amphotericin B at primary-health-care centres. Once the elimination target of one case per 10,000 population has been reached, combination therapies involving miltefosine and paromomycin can be introduced to ensure long-term availability of several drugs for visceral leishmaniasis and to protect against resistance.
    No preview · Article · Apr 2011 · The Lancet Infectious Diseases
  • Nilima Kshirsagar · Robin Ferner · Byron Alfredo Arana Figueroa · Hashim Ghalib · Janis Lazdin
    [Show abstract] [Hide abstract]
    ABSTRACT: Pharmacovigilance is concerned with the assessment of benefit and harm. Disease burden, status of healthcare delivery through government centres and practitioners, existing pharmacovigilance programmes, relevant pre-marketing studies and the likely effectiveness and risks of drugs must be considered for planning pharmacovigilance activity. The risk of a drug may be known, unknown, potential or specific to the context of the programme. The potential benefits of a public health programme aimed at reducing or eliminating a specific condition will depend on the health burden due to that condition, which is a function of the seriousness of the condition and its frequency, as well as the likely efficacy of the programme in reaching its goals. The present article has outlined an approach to pharmacovigilance for such a donor-funded programme, using pharmacovigilance in leishmaniasis as an example.
    No preview · Article · Feb 2011 · Transactions of the Royal Society of Tropical Medicine and Hygiene
  • [Show abstract] [Hide abstract]
    ABSTRACT: The combination of one intravenous administration of 5mg/kg Ambisome and oral administration of miltefosine, 2.5mg/kg/day for 14 days, was evaluated in 135 Indian patients with kala-azar. The Intent-to-Treat cure rate at 6 months was 124 of the 135 enrolled patients (91.9%: 95% CI = 86-96%), and the per protocol cure rate was 124 of 127 evaluable patients (97.6%: 95% CI = 93-100%). Side effects could be attributed to each drug separately: fevers, rigors and back pain due to Ambisome; gastrointestinal side effects due to miltefosine. This combination is attractive for reasons of efficacy, tolerance, and feasibility of administration, although the gastrointestinal side effects of miltefosine require medical vigilance. Clinical Trials.gov identification number: NCT00371995.
    No preview · Article · Feb 2011 · Transactions of the Royal Society of Tropical Medicine and Hygiene
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: The promotion of point-of-use water treatment and handwashing with soap has led to large reductions in child diarrhea in randomized efficacy trials. We know little about the sustainability of behavior change and health benefits after the conclusion of intervention activities. Methods: We present an extension of previously published design (propensity score matching) and analysis (targeted maximum likelihood estimation) methods to evaluate the sustainability and health impacts of a pre-existing (non-randomized) intervention (a three-year, combined point-of-use water treatment and handwashing campaign in rural Guatemala). Six months after the intervention, we conducted a cross-sectional cohort study in 30 villages (15 intervention, 15 control) that included 600 households and 929 children under five years old. Results: The design created a sample of intervention and control villages that were comparable across more than 30 potentially confounding characteristics. The intervention was associated with modest gains in confirmed water treatment behavior (risk difference=0.05, 95%CI 0.02-0.09). We found, however, no differences between the intervention and control villages in self-reported handwashing behavior, spot-check hygiene conditions, the prevalence of either child diarrhea or clinical acute lower respiratory infections, or child growth. Conclusions: To our knowledge this is the first post-intervention follow-up study of a combined point-of-use water treatment and handwashing behavior change intervention, and the first post-intervention follow-up of either intervention type to include child health measurement. Our findings highlight the difficulty of sustaining behavior-based point-of-use water treatment and handwashing outside of intensive efficacy trials.
    No preview · Conference Paper · Nov 2009

  • No preview · Article · Nov 2009 · Epidemiology

22 Following View all

82 Followers View all