MedTrace Logo

Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh

NCT00844337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2490

Last updated 2014-09-16

No results posted yet for this study

Summary

The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days.

Hypothesis

The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points.

Secondary Objectives:

* To identify baseline clinical predictors of treatment failure in severe infections in young infants.
* To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14).

Conditions

Interventions

DRUG

Gentamicin & Amoxicillin x 7days

Injectable gentamicin once daily and oral amoxicillin twice daily for seven days. The dose for gentamicin is 4 - 5 mg/kg/24 hours. The dose for amoxicillin is 90-115 mg/kg/day.

DRUG

Penicillin & gentamicin x 2 d + Amoxicillin X 5 d

Injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days. The dose for penicillin is 40,000 - 50,000 U/kg/24 hours, the dose for gentamicin is 4 - 5 mg/kg/24 hours, and the dose for amoxicillin is 90-115 mg/kg/day.

DRUG

Standard reference therapy

Injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. The penicillin dose is 40,000 - 50,000 U/kg/24 hours, and the gentamicin dose is 4 - 5 mg/kg/24 hours.

Sponsors & Collaborators

  • Dhaka Shishu Hospital

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Abdullah H Baqui, MBBSMPHDrPH · Johns Hopkins University Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
59 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

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 NCT00844337 on ClinicalTrials.gov