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Optimizing place of treatment for young infants presenting with any low mortality risk sign of possible serious bacterial infection

Optimizing place of treatment for young infants presenting with any low mortality risk sign of possible serious bacterial infection-Study 1 - PSBI RCT 1

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029776
Enrollment
1000
Registered
2020-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A499- Bacterial infection, unspecified

Interventions

Intervention1: Outpatient treatment with Inj Gentamicin and oral Amoxicillin: Inj Gentamicin (I/M) OD x 2 days Syrup Amoxicillin (oral) BD x 7 days Control Intervention1: Inpatient treatment with Inj

Sponsors

Centre for Health Research and Development Society for Applied Studies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All young infants 1. Body temperature >=38°C, or 2. Severe chest indrawing, or 3. Fast breathing (

Exclusion criteria

Exclusion criteria: 1. Weight 2. Signs of critical illness (no movement at all, unable to feed at all, convulsions), or 3.Signs of CSI associated with a high risk of mortality (stopped feeding well, movement only on stimulation, low body temperature 4. Any sign suggestive of another serious illness/condition, such as major congenital malformations, severe jaundice, conditions requiring major surgery, meningitis, bone or joint infection, severe dehydration, etc., or 5. Appearance of low-mortality risk signs in first 24 hours of life , or 6. Hospitalized for any illness in the previous 2 weeks, or 7. Prior use of injectable antibiotics for the same illness, or 8. Previously included in this study or currently included in any other study

Design outcomes

Primary

MeasureTime frame
Death Presence of any sign of critical illness or sign suggestive of another serious infection Presence of any new sign of CSI Persistence of presenting sign Timepoint: Day 1-15 Days 2, 4, 8 Days 4, 8, Day 8

Secondary

MeasureTime frame
Not knownTimepoint: Not known

Countries

India

Contacts

Public ContactTemsunaro Rongsen Chandola

Centre for Health Research and Development, Society for Applied Studies

naro@sas.org.in011-46043751-55

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026