Trial reportThe Pediatric infectious disease journal2013
Safety and efficacy of simplified antibiotic regimens for outpatient treatment of serious infection in neonates and young infants 0-59 days of age in Bangladesh: design of a randomized controlled trial.
Trial report in The Pediatric infectious disease journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03750747 (Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services to Manage Acute Respiratory Infections at First Level Health Facilities of Bangladesh), which is not on this map. Cited by 14 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services to Manage Acute Respiratory Infections at First Level Health Facilities of Bangladesh
Who cites it
14 citing papers in PubMed, 6 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Antibiotic regimens for early-onset neonatal sepsis.The Cochrane database of systematic reviews · 2021Pooled it
- Antibiotic regimens for late-onset neonatal sepsis.The Cochrane database of systematic reviews · 2021Pooled it
- Community-based maternal and newborn educational care packages for improving neonatal health and survival in low- and middle-income countries.The Cochrane database of systematic reviews · 2019Pooled it
- Community-based antibiotic delivery for possible serious bacterial infections in neonates in low- and middle-income countries.The Cochrane database of systematic reviews · 2019Pooled it
- Feasibility and efficacy of gentamicin for treating neonatal sepsis in community-based settings: a systematic review.World journal of pediatrics : WJP · 2016Pooled it
- Treatment of infections in young infants in low- and middle-income countries: a systematic review and meta-analysis of frontline health worker diagnosis and antibiotic access.PLoS medicine · 2014Pooled it
- Simplified antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in Pakistan (Simplified Antibiotic Therapy Trial [SATT]): a randomised, open-label, equivalence trial.The Lancet. Global health · 2017Trial
- Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.The Pediatric infectious disease journal · 2013Trial
- Oral amoxicillin plus gentamicin regimens may be superior to the procaine-penicillin plus gentamicin regimens for treatment of young infants with possible serious bacterial infection when referral is not feasible: Pooled analysis from three trials in Africa and Asia.Journal of global health · 2022Article
- Dose Rationale for Amoxicillin in Neonatal Sepsis When Referral Is Not Possible.Frontiers in pharmacology · 2020Article
- Ongoing trials of simplified antibiotic regimens for the treatment of serious infections in young infants in South Asia and sub-Saharan Africa: implications for policy.The Pediatric infectious disease journal · 2013Article
- Ensuring quality in AFRINEST and SATT: clinical standardization and monitoring.The Pediatric infectious disease journal · 2013Article
- An innovative multipartner research program to address detection, assessment and treatment of neonatal infections in low-resource settings.The Pediatric infectious disease journal · 2013Review
- Scientific rationale for study design of community-based simplified antibiotic therapy trials in newborns and young infants with clinically diagnosed severe infections or fast breathing in South Asia and sub-Saharan Africa.The Pediatric infectious disease journal · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 8 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBecause access to care is limited in settings with high mortality, exclusive reliance on the current recommendation of 7-10 days of parenteral antibiotic treatment is a barrier to provision of adequate treatment of newborn infections.
methodsWe are conducting a trial to determine if simplified antibiotic regimens with fewer injections are as efficacious as the standard course of parenteral antibiotics for empiric treatment of young infants with clinical signs suggestive of severe infection in 4 urban hospitals and in a rural surveillance site in Bangladesh. The reference regimen of intramuscular procaine-benzyl penicillin and gentamicin given once daily for 7 days is being compared with (1) intramuscular gentamicin once daily and oral amoxicillin twice daily for 7 days and (2) intramuscular penicillin and gentamicin once daily for 2 days followed by oral amoxicillin twice daily for additional 5 days. All regimens are provided in the infant's home. The primary outcome is treatment failure (death or lack of clinical improvement) within 7 days of enrolment. The sample size is 750 evaluable infants enrolled per treatment group, and results will be reported at the end of 2013. DISCUSSION: The trial builds upon previous studies of community case management of clinical severe infections in young infants conducted by our research team in Bangladesh. The approach although effective was not widely accepted in part because of feasibility concerns about the large number of injections. The proposed research that includes fewer doses of parenteral antibiotics if shown efficacious will address this concern.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.