Antibiotic regimens for suspected late onset sepsis in newborn infants

Royal Prince Alfred Hospital, Missenden Road, Sydney, NSW, Australia, 2050.
Cochrane database of systematic reviews (Online) (Impact Factor: 6.03). 02/2005; 3(3):CD004501. DOI: 10.1002/14651858.CD004501.pub2
Source: PubMed


Antibiotics for newborn infants that might have blood infections when more than 48 hours old. Blood infection (sepsis) can make newborn infants seriously ill or even kill them. Sepsis in newborns more than 48 hours old is called late onset neonatal sepsis; it is usually caused by bacteria, and sometimes by fungal infection. Doctors often give antibiotics if they suspect this dangerous condition as it can be difficult to tell if a newborn has late onset neonatal sepsis. Certain antibiotics given for this condition can have serious side effects, including antibiotic resistance, which can result in worse infection. This Cochrane review examined which antibiotics are best for treating late onset neonatal sepsis, in terms of effectiveness and side effects. The authors searched the medical literature and found only one study that met all the criteria the authors were looking for. This study, from 1988, enrolled 28 newborn infants. Some of the newborns received a beta lactam antibiotic by itself while others got the beta lactam plus another antibiotic, an aminoglycoside. There were no significant differences between the two kinds of antibiotic treatment in this study. The Cochrane review authors concluded that there is not enough research to recommend one kind of antibiotic treatment over another for late onset neonatal sepsis.


Available from: Heather E Jeffery
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    • "For early onset neonatal sepsis (<48 hours), monotherapy versus combination therapy showed a decrease in mmortality in the first 28 days of life (RR 0.75; 95 % CI: 0.19, 2.90) [72]. For late onset neonatal sepsis, Beta-lactam antibiotics versus a combination of beta-lactam plus aminoglycoside decreased mortality prior to discharge (RR 0.17; 95% CI: 0.01, 3.23); and also a reduction in treatment failure (RR 0.17; 95 % CI: 0.01, 3.23) [73]. The case-management for pneumonia showed reduction in total mortality by 27% (95% CI 18,35%) and pneumonia specific mortality by 42% (22-57%) [74]. "
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    ABSTRACT: Childbirth and the postnatal period, spanning from right after birth to the following several weeks, presents a time in which the number of deaths reported still remain alarmingly high. Worldwide, about 800 women die from pregnancy- or childbirth-related complications daily while almost 75% of neonatal deaths occur within the first seven days of delivery and a vast majority of these occur in the first 24 hours. Unfortunately, this alarming trend of mortality persists, as287,000 women lost their lives to pregnancy and childbirth related causes in 2010. Almost all of these deaths were preventable and occurred in low-resource settings, pointing towards dearth of adequate facilities in these parts of the world. The main objective of this paper is to review the evidence based childbirth and post natal interventions which have a beneficial impact on maternal and newborn outcomes. It is a compilation of existing, new and updated interventions designed to help physicians and policy makers and enable them to reduce the burden of maternal and neonatal morbidities and mortalities. Interventions during the post natal period that were found to be associated with a decrease in maternal and neonatal morbidity and mortality included: advice and support of family planning, support and promotion of early initiation and continued breastfeeding; thermal care or kangaroo mother care for preterm and/or low birth weight babies; hygienic care of umbilical cord and skin following delivery, training health personnel in basic neonatal resuscitation; and postnatal visits. Adequate delivery of these interventions is likely to bring an unprecedented decrease in the number of deaths reported during childbirth.
    Reproductive Health 08/2014; 11(Suppl 1):S3. DOI:10.1186/1742-4755-11-S1-S3 · 1.88 Impact Factor
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    • "Lack of safety and efficacy data in neonates were also issues of concern. In fact, despite their wide use, antibiotics have not been broadly compared for safety and efficacy in the treatment of suspected neonatal sepsis [16, 25]. A retrospective cohort study of premature babies found no effect on linear growth due to ciprofloxacin exposure after 12 months [26]. "
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    ABSTRACT: Purpose To describe the use of ciprofloxacin and fluconazole for the treatment of sepsis in European neonatal intensive care units (NICUs) in order to better orient research aimed at acquiring essential knowledge in this critical area. Methods The survey consisted of an online questionnaire for all participating NICUs on treatment schemes employed, rationales behind drug choices and interest in participation in research involving the two drugs. Results A total of 189 level II and III NICUs participated in the survey, representing 25 countries, with Italy, UK and France providing the greatest number of centres (54 % of total). Ciprofloxacin is used in 25 % of NICUs that responded, although the indications for administering it vary between centres and the dosage ranges vary considerably, with 25 % of NICUs giving ≤10 mg/kg/day and another 25 % giving ≥21 mg/kg/day. Factors given as affecting the decision to use ciprofloxacin are uncertainty about its safety and pharmacokinetics and level of penetration in the cerebrospinal fluid. Among the 70 % of responding units that use fluconazole to treat fungal infection, 45 % administer 6 mg/kg unit doses while 33 % administer 12 mg/kg; 41 % of NICUs use a 24-h interval between administrations while 20 % wait 72 h. Among the responding NICUs, 57 % were willing to participate in a project on ciprofloxacin and 59 % would consider participating in a randomized controlled trial evaluating fluconazole versus micafungin. Conclusions Great variability in therapies exists within and between countries. Numerous centres are interested in participating in research on these drugs, highlighting the need for further knowledge on sepsis treatment and European centres’ interest in off-patent medicine research.
    European Journal of Clinical Pharmacology 10/2012; 69(4). DOI:10.1007/s00228-012-1415-2 · 2.97 Impact Factor
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    • "Despite the fact that a number of clinical studies in neonatal sepsis have been conducted previously, several methodological issues and the changing patient population make their results out of date and not applicable to the present population affected by LOS. It is remarkable that all 13 randomised controlled trials (RCT) are relatively old, dating from 1973 to 1992 [20]. With the exception of two studies, [21,22] data on EOS and LOS were combined and neonatal and paediatric patients were reported together [23,24]. "
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    ABSTRACT: Background Late onset neonatal sepsis (LOS) with the mortality of 17 to 27% is still a serious disease. Meropenem is an antibiotic with wide antibacterial coverage. The advantage of it over standard of care could be its wider antibacterial coverage and thus the use of mono-instead of combination therapy. Methods NeoMero-1, an open label, randomised, comparator controlled, superiority trial aims to compare the efficacy of meropenem with a predefined standard of care (ampicillin + gentamicin or cefotaxime + gentamicin) in the treatment of LOS in neonates and infants aged less than 90 days admitted to a neonatal intensive care unit. A total of 550 subjects will be recruited following a 1:1 randomisation scheme. The trial includes patients with culture confirmed (at least one positive culture from normally sterile site except coagulase negative staphylococci in addition to one clinical or laboratory criterion) or clinical sepsis (at least two laboratory and two clinical criteria suggestive of LOS in subjects with postmenstrual age < 44 weeks or fulfilment of criteria established by the International Pediatric Sepsis Consensus Conference in subjects with postmenstrual age ≥ 44 weeks). Meropenem will be given at a dose of 20 mg/kg q12h or q8h depending on the gestational- and postnatal age. Comparator agents are administered as indicated in British National Formulary for Children. The primary endpoint measured at the test of cure visit (2 days after end of study therapy) is graded to success (all baseline symptoms and laboratory parameters are resolved or improved with no need to continue antibiotics and the baseline microorganisms are eradicated and no new microorganisms are identified and the patient has received allocated treatment for 11 ± 3 days with no modification) or a failure (all remaining cases). Secondary outcome measures include comparison of survival, relapse rates or new infections by Day 28, clinical response at Day 3 and end of therapy, duration of hospitalisation, population pharmacokinetic analysis of meropenem and effect of antibiotics on mucosal colonisation and development of antibacterial resistance. The study will start recruitment in September 2011; the total duration is of 24 months. Trial registration EudraCT 2011-001515-31
    Trials 09/2011; 12(1):215. DOI:10.1186/1745-6215-12-215 · 1.73 Impact Factor
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