Simplified Regimens for Management of Possible Serious Bacterial Infections in Neonates and Young Infants for Use in Outpatient and Community Settings: A multi-centre Randomized Controlled Trial in Africa

Phase 3

• Conditions: Possible serious bacterial infection; Infection - Other infectious diseases

• Registration Number: ACTRN12610000286044
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6900

Inclusion Criteria

Stratum 1 (severe infection): One or more of the following five signs of 'severe infection' - not feeding well, movement only when stimulated, severe chest indrawing, axillary temperature >38.0 degree Centigrade or <35.5 degree Centigrade and informed consent is provided by a parent (or legal guardian).

Stratum II (fast breathing only): Fast breathing i.e., respiratory rate 60 or more per minute and Informed consent is provided by a parent (or legal guardian)

Exclusion Criteria

Stratum I: Exclusion Criteria
- Critically ill infant characterized by presence of any of the following signs - unconscious, convulsions, unable to feed at all, apnea, unable to cry, cyanosis, bulging fontanelle, major congenital malformations inhibiting oral antibiotic intake, active bleeding requiring transfusion, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour
- Very low weight (<1500g at the time of presentation)
- Hospitalization for illness in the last two weeks
- Previous inclusion in the study

Stratum II: Exclusion Criteria
- Any signs of severe infection: not feeding well, movement only when stimulated, severe chest in-drawing, axillary temperature >38.0 degree Centigrade or <35.5 degree Centigrade ,
- Any sign of being critically ill
- Very low weight (<1500g at the time of presentation)
- Hospitalization for illness in the last two weeks
- Previous inclusion in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified