Simplified Antibiotic Therapy for Sepsis in Young Infants (SATT)

June 26, 2015 updated by: Anita Kaniz Mehdi Zaidi, Aga Khan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2543

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Ali Akber Shah Goth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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
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.
Experimental: 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
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.
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
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment failure
Time Frame: within 7 days of enrolment
within 7 days of enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

London School of Hygiene and Tropical Medicine
Emory University
World Health Organization
Save the Children

Investigators

  • Study Director: Shiyam S Sunder, MBBS, The Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC134GL50124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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