drugset / Trial / NCT01027429
Simplified Antibiotic Therapy for Sepsis in Young Infants
Phase 3
Completed
2543 enrolled
Aga Khan University
Emory University · collabLondon School of Hygiene and Tropical Medicine · collabSave the Children · collabWorld Health Organization · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.
Timeline
- Start
- 2009-12
- Primary completion
- 2013-12
- Completion
- 2013-12
Publications
- Longombe AL, Ayede AI, Marete I, Mir F, Ejembi CL, Shahidullah M, Adejuyigbe EA, Wammanda RD, Tshefu A, Esamai F, Zaidi AK, Baqui AH, Cousens S. 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. J Glob Health. 2022 Nov 21;12:04084. doi: 10.7189/jogh.12.04084.
- Mir F, Pearce RE, Baig-Ansari N, Qazi S, Barrett JS, Abdel-Rahman S, Kearns G, Zaidi AK. Serum amoxicillin levels in young infants (0-59 days) with sepsis treated with oral amoxicillin. Arch Dis Child. 2020 Dec;105(12):1208-1214. doi: 10.1136/archdischild-2019-317342. Epub 2020 May 13.
- Mir F, Nisar I, Tikmani SS, Baloch B, Shakoor S, Jehan F, Ahmed I, Cousens S, Zaidi AK. 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. Lancet Glob Health. 2017 Feb;5(2):e177-e185. doi: 10.1016/S2214-109X(16)30335-7. Epub 2016 Dec 15.
- Zaidi AK, Tikmani SS, Sultana S, Baloch B, Kazi M, Rehman H, Karimi K, Jehan F, Ahmed I, Cousens S. 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. Pediatr Infect Dis J. 2013 Sep;32 Suppl 1(Suppl 1 Innovative Treatment Regimens for Severe Infections in Young Infants):S19-25. doi: 10.1097/INF.0b013e31829ff7aa.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 80 mg/kg | Oral |
| Subject | Amoxicillin | Other / unclassified | 90 mg/kg | Oral |
| Comparator | PROCAINE BENZYLPENICILLIN | Small molecule | 50000 iu/kg | Intramuscular |
| Comparator | Gentamicin | Small molecule | 5 mg/kg | Intramuscular |