Status:
UNKNOWN
Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants
Lead Sponsor:
Aga Khan University
Conditions:
Bacterial Infection
Sepsis
Eligibility:
All Genders
Up to 59 years
Phase:
PHASE3
Brief Summary
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Heal...
Eligibility Criteria
Inclusion
- Age 0-59 days presenting to Young Infant community study site
- Clinical diagnosis of possible serious bacterial infection by study physician according to specified clinical criteria
- Parents refuse to accept referral care and sign (or thumb imprint) document stating this.
- Parents consent to community centre-based intramuscular antibiotic injections
Exclusion
- Age over 59 days
- Presence of severe jaundice diagnosed clinically or by laboratory investigation (bilirubin \> 12 g/dl in term and \> 7 in pre-term baby).
- Presence of obvious meningitis (bulging fontanelle, observed seizures)
- Patient previously enrolled in antibiotic therapy trial
- Parents accept hospital referral
- Parents do not consent to any injectable therapy
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT00189384
Start Date
November 1 2003
End Date
December 1 2005
Last Update
September 11 2006
Active Locations (1)
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1
Aga Khan University community field sites
Karachi, Sindh, Pakistan, 74800