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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


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.


Minimum age: N/A. Maximum age: 59 Days. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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