Trial reportThe Pediatric infectious disease journal2013
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.
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 NCT03871491 (Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor), which is not on this map. Cited by 21 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial
Who cites it
21 citing papers in PubMed, 8 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Prevention and Treatment of Neonatal Infections in Facility and Community Settings of Low- and Middle-Income Countries: A Descriptive Review.Neonatology · 2025Pooled it
- 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
- Estimates of possible severe bacterial infection in neonates in sub-Saharan Africa, south Asia, and Latin America for 2012: a systematic review and meta-analysis.The Lancet. Infectious diseases · 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
- Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Trial
- Article
- Article
- 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
- Simplified Dosing Regimens for Gentamicin in Neonatal Sepsis.Frontiers in pharmacology · 2021Article
- Dose Rationale for Amoxicillin in Neonatal Sepsis When Referral Is Not Possible.Frontiers in pharmacology · 2020Article
- A retrospective study of neonatal case management and outcomes in rural Rwanda post implementation of a national neonatal care package for sick and small infants.BMC pediatrics · 2018Article
- Knowledge, attitudes and practices related to tetanus toxoid vaccination in women of childbearing age: A cross-sectional study in peri-urban settlements of Karachi, Pakistan.Journal of infection prevention · 2017Article
- Ensuring quality in AFRINEST and SATT: clinical standardization and monitoring.The Pediatric infectious disease journal · 2013Article
- 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
- 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
Corrections and comments
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Authors and funding
10 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundInfection in young infants is a major cause of morbidity and mortality in low-middle income countries, with high neonatal mortality rates. Timely case management is lifesaving, but the current standard of hospitalization for parenteral antibiotic therapy is not always feasible. Alternative, simpler antibiotic regimens that could be used in outpatient settings have the potential to save thousands of lives.
methodsThis trial aims to determine whether 2 simplified antibiotic regimens are equivalent to the reference therapy with 7 days of once-daily (OD) intramuscular (IM) procaine penicillin and gentamicin for outpatient management of young infants with clinically presumed systemic bacterial infection treated in primary health-care clinics in 5 communities in Karachi, Pakistan. The reference regimen is close to the current recommendation of the hospital-based intravenous ampicillin and gentamicin therapy for neonatal sepsis. The 2 comparison arms are (1) IM gentamicin OD and oral amoxicillin twice daily for 7 days; and (2) IM penicillin and gentamicin OD for 2 days, followed by oral amoxicillin twice daily for 5 days; 2250 "evaluable" infants will be enrolled. The primary outcome of this trial is treatment failure (death, deterioration or lack of improvement) within 7 days of enrollment. Results are expected by early 2014. DISCUSSION: This trial will determine whether simplified antibiotic regimens with fewer injections in combination with high-dose amoxicillin are equivalent to 7 days of IM procaine penicillin and gentamicin in young infants with clinical severe infection. Results will have program and policy implications in countries with limited access to hospital care and high burden of neonatal deaths.
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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.