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Simplified Antibiotic Therapy for Sepsis in Young Infants

NCT01027429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2543

Last updated 2015-06-29

No results posted yet for this study

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

Interventions

DRUG

procaine penicillin and gentamicin

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

DRUG

amoxicillin and gentamicin

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

DRUG

procaine penicillin, gentamicin, amoxicillin

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.

Sponsors & Collaborators

  • Save the Children

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Shiyam S Sunder, MBBS · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
59 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Pakistan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027429 on ClinicalTrials.gov