Simplified Antibiotic Therapy for Sepsis in Young Infants

Sepsis Clinical Trial

— SATT  

Official title:

Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027429
• Other study ID #: SC134GL50124
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2009
• Last updated: June 26, 2015
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Nations: World Health Organization
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2543
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 59 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Drug:
• 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
• 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
• 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.

Locations

Country	Name	City	State
Pakistan	Ali Akber Shah Goth	Karachi	Sindh

Sponsors (5)

Lead Sponsor	Collaborator
Aga Khan University	Emory University, London School of Hygiene and Tropical Medicine, Save the Children, World Health Organization

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure		within 7 days of enrolment	Yes