Status:
COMPLETED
Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Dhaka Shishu Hospital
Conditions:
Sepsis
Eligibility:
All Genders
Up to 59 years
Phase:
NA
Brief 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 suspect...
Detailed Description
Although many developing countries have witnessed declines in both post-neonatal and 1-4 year-old child deaths, neonatal death rates have remained relatively constant, with an estimated 4 million annu...
Eligibility Criteria
Inclusion
- Infants 0-59 days old who are residents of catchment population of the study hospitals
- One or more of the following five signs: severe chest in-drawing, axillary temperature \>37.80C or \<35.50 C, lethargic or less than normal movement, 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.
Exclusion
- 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, 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, and/or physician's suspicion of meningitis)
- Very low birth weight: weight \<1500
- Hospitalization for illness in the last two weeks
- Hospital born infants
- Previous inclusion in the study
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
2490 Patients enrolled
Trial Details
Trial ID
NCT00844337
Start Date
March 1 2009
End Date
September 1 2013
Last Update
September 16 2014
Active Locations (3)
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1
Dhaka Shishu Hospital/CHRF
Dhaka, Dhaka Division, Bangladesh, 1216
2
Chittagong Ma O Shishu Hospital
Chittagong, Bangladesh
3
Shishu Shastya Foundation
Dhaka, Bangladesh