Simplified Antibiotic Therapy for Sepsis in Young Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Sepsis Sepsis Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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procaine penicillin and gentamicin

Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days

Group Type ACTIVE_COMPARATOR

procaine penicillin and gentamicin

Intervention Type DRUG

procaine penicillin 50,000 units/kg by intramuscular injection once daily for 7 days; gentamicin, 5 mg/kg once daily by intramuscular injection for 7 days

procaine penicillin, gentamicin, amoxicillin

Intervention Type DRUG

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Amoxicillin and gentamicin

Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days

Group Type EXPERIMENTAL

amoxicillin and gentamicin

Intervention Type DRUG

oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days

procaine penicillin, gentamicin, amoxicillin

Intervention Type DRUG

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

procaine penicillin, gentamicin, and amoxicillin

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Group Type EXPERIMENTAL

procaine penicillin, gentamicin, amoxicillin

Intervention Type DRUG

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Interventions

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procaine penicillin and gentamicin

procaine penicillin 50,000 units/kg by intramuscular injection once daily for 7 days; gentamicin, 5 mg/kg once daily by intramuscular injection for 7 days

Intervention Type DRUG

amoxicillin and gentamicin

oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days

Intervention Type DRUG

procaine penicillin, gentamicin, amoxicillin

procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

59 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No