Simplified Antibiotic Therapy for Sepsis in Young Infants
Information source: Aga Khan University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Sepsis; Sepsis; Infection
Intervention: procaine penicillin and gentamicin (Drug); amoxicillin and gentamicin (Drug); procaine penicillin, gentamicin, amoxicillin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Aga Khan University Official(s) and/or principal investigator(s): Shiyam S Sunder, MBBS, Study Director, Affiliation: The Aga Khan University
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.
Clinical Details
Official title: Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Treatment failure
Detailed description:
Primary Objective
To evaluate if out-patient (clinic-based) therapy of young infants with possible serious
bacterial infection with 7 days of intramuscular procaine penicillin and gentamicin
(reference therapy) is equivalent to:
- (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
Hypothesis
The proportion of babies who fail therapy at (or before 7) days will be 10% in each group. A
5% or less difference in failure rates will be considered equivalent.
Study Design
This will be a randomized, three arm, open-label equivalence trial among young infants, 0-59
days of age who are diagnosed as having possible serious bacterial infection in one of the
Karachi field clinics, and whose families refuse facilitated hospital referral, and the
infants meet other specified inclusion criteria.
Eligible young infants will be recruited from among those referred to the clinics by trained
community health workers as having clinical signs predictive of possible serious illness
during regular home visits in the surveillance area, or those presenting directly to the
clinics from the areas under pregnancy and newborn surveillance. A diagnosis of possible
sepsis will be made by clinicians if specified clinical criteria are met.
Eligibility
Minimum age: N/A.
Maximum age: 59 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Inclusion Criteria
- 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.
- Exclusion Criteria:
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
- Previous inclusion in the study
Locations and Contacts
Ali Akber Shah Goth, Karachi, Sindh 74800, Pakistan
Additional Information
Starting date: December 2009
Last updated: June 26, 2015
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