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Optimizing duration of hospitalization for young infants with sepsis

Optimizing duration of hospitalization for young infants presenting with any moderate mortality risk sign of possible serious bacterial infection-Study 2 - PSBI RCT 2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029623
Enrollment
750
Registered
2020-12-07
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 oral Amoxicillin: Syrup Amoxicillin (oral) BD x 5 days Control Intervention1: Inpatient treatment with Inj Gentamicin and Inj Ampicillin: Inj Gentamicin OD x 5

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: All patients admitted to the study hospitals with relatively higher-mortality risk signs of CSI at presentation (not feeding well, movement only on stimulation, low body temperature 1. Clinically well on day 3 defined as absence of all signs of critical illness (not feeding at all, no movement at all, convulsions) or CSI (not feeding well, movement only when stimulated, low body temperature ( =38oC), severe chest indrawing, fast breathing in 2. Laboratory test negative, and 3. Family lives within a catchment area where a follow-up of up to day 15 can be accomplished.

Exclusion criteria

Exclusion criteria: 1. Weight 2. Signs of critical illness on admission (no movement at all, unable to feed at all, or convulsions), or 3. Appearance of any high-mortality risk sign or multiple low-mortality risk signs in first 24 hours of life, or 4. Hospitalized for any illness in the previous 2 weeks, or 5. Prior use of injectable antibiotics for the same illness, or 6. Previously included in this study or currently included in any other study, or 7. Any other reason to stay in hospital, as decided by the treating physician

Design outcomes

Primary

MeasureTime frame
Death Presence of any sign of critical illness or sign suggestive of another serious infection Presence of any sign of CSITimepoint: Randomization to Day 15 Day 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