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Community-Based Treatment of Serious Bacterial Infections in Newborns and Young Infants: A Randomized Controlled Trial Assessing Three Antibiotic Regimens.
MedLine Citation:
PMID:  22481421     Owner:  NLM     Status:  Publisher    
BACKGROUND:: Sepsis in the neonatal period is a major cause of child mortality in low-income countries. Hospitalization and parenteral penicillin/ampicillin and gentamicin therapy is recommended for management. Many families, however, are unable to access hospital care, and most home-delivered newborns who develop sepsis die without receiving antibiotic therapy. Appropriate community-based therapy in such situations is undefined. We compared failure rates of three clinic-based antibiotic regimens in 0-59 day-old infants with possible serious bacterial infection (PSBI) whose families refused hospitalization in Karachi communities with high neonatal mortality rates (NMR) >45/1000 live births. METHODS:: Eligible infants were randomly assigned to 7 days of: (i) procaine penicillin [50,000 units/kg once daily (OD) by intramuscular injection (IM)] and gentamicin (5 mg/kg OD IM) reference arm, or (ii) ceftriaxone (50 mg/kg OD IM), or (iii) oral trimethoprim-sulfamethoxazole (TMP-SMX) at 10 mg/kg/day divided twice daily and gentamicin IM OD. Primary outcome was treatment failure, defined as death, deterioration in clinical condition during therapy, or no improvement after 2 days. RESULTS:: PSBI was diagnosed in 704 infants, among 5766 screened. Among 434 (61.6%) randomized to clinic-based therapy, there were 13/145 failures with penicillin-gentamicin, 22/145 with ceftriaxone, and 26/143 with TMP-SMX-gentamicin. Treatment failure was significantly higher with TMP-SMX-gentamicin compared to penicillin-gentamicin [relative risk (RR) 2.03, 95% CI: 1.09-3.79] by intention to treat analysis. Differences were not significant in the ceftriaxone vs. penicillin-gentamicin comparison [RR 1.69, 95% CI 0.89 - 3.23). By 14 days, there were 2 deaths in the penicillin-gentamicin group, 3 in the ceftriaxone group, and 11 in the TMP-SMX-gentamicin group [RR 5.58, 95% CI: 1.26 - 24.72 (group 3 vs. 1)]. CONCLUSION:: When hospitalization of sick infants is unfeasible, out-patient therapy with injectable antibiotics is an effective option. Procaine penicillin-gentamicin was superior to TMP-SMX-gentamicin. Ceftriaxone is a more expensive option, and may be less effective, although this requires further research.
Anita K M Zaidi; Shiyam Sundar Tikmani; Haider J Warraich; Gary L Darmstadt; Zulfiqar A Bhutta; Shazia Sultana; Durrane Thaver
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-4-4
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  -     ISSN:  1532-0987     ISO Abbreviation:  -     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-4-6     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
1Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan 2International Center for Advancing Neonatal Health, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
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