Simplified Antibiotic Therapy for Sepsis in Young Infants

NCT01027429 | Completed Phase 3 DMC

• 1 other identifier: SC134GL50124
• Study Type: interventional
• Target: 2,543
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Sepsis; Sepsis; Infection

Keywords

infant; newborn; sepsis; infection; community

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  within 7 days of enrolment

Study Arms (3)

procaine penicillin and gentamicin

ACTIVE COMPARATOR

Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days

Drug: procaine penicillin and gentamicin; Drug: procaine penicillin, gentamicin, amoxicillin

Amoxicillin and gentamicin

EXPERIMENTAL

Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days

Drug: amoxicillin and gentamicin; Drug: procaine penicillin, gentamicin, amoxicillin

procaine penicillin, gentamicin, and amoxicillin

EXPERIMENTAL

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Drug: procaine penicillin, gentamicin, amoxicillin

Interventions

procaine penicillin and gentamicin DRUG

procaine penicillin 50,000 units/kg by intramuscular injection once daily for 7 days; gentamicin, 5 mg/kg once daily by intramuscular injection for 7 days

procaine penicillin and gentamicin

amoxicillin and gentamicin DRUG

oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days

Amoxicillin and gentamicin

procaine penicillin, gentamicin, amoxicillin DRUG

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Amoxicillin and gentamicin; procaine penicillin and gentamicin; procaine penicillin, gentamicin, and amoxicillin

Eligibility Criteria

• Age: Up to 59 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 0-59 days old who are residents of catchment population of the study hospitals or clinics
• One or more of the following five signs: severe chest in-drawing, axillary temperature \>38.0C or \<35.50 C, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment)
• Family refuses recommended hospitalization or hospitalization otherwise not feasible
• Informed consent by a legal guardian.

You may not qualify if:

• Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour)
• Very low birth weight: weight \<1500
• Hospitalization for illness in the last two weeks

Sponsors & Collaborators

• Aga Khan University: lead
• Save the Children: collaborator
• World Health Organization: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Emory University: collaborator

Study Sites (1)

Ali Akber Shah Goth

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 36403158 DERIVED

• 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.

  PMID: 32404437 DERIVED

• 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.

  PMID: 27988146 DERIVED

• 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.

  PMID: 23945571 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis; Sepsis; Infections

Interventions

Penicillin G Procaine; Gentamicins; Amoxicillin

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Procaine; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Ampicillin

Study Officials

• Shiyam S Sunder, MBBS

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Paediatrics and Child Health

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 8, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

PA (1)