A clinical trial to compare the effectiveness of outpatient care with simplified antibiotic regimens vs. standard inpatient care in treating infants aged 0-59 days with clinical severe infection or fast breathing pneumonia.
- Conditions
- Health Condition 1: A30-A49- Other bacterial diseases
- Registration Number
- CTRI/2020/11/029309
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1961
1) Study-1: All young infants <2 months old, living in the study area where follow-up for 14 days can be accomplished presenting to outpatient clinics or emergency rooms of participating hospitals will be considered for inclusion in this study if they have ONLY one of the following low-risk signs of PSBI:
- Body temperature = 38°C, or
- Severe chest indrawing, or
- Fast breathing ( <7 days old infants only).
2) Study-2: All young infants <2 months old, living in the study area where follow-up for 14 days can be accomplished, and 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 < 35.5oC, two or more of the six signs of CSI) will be assessed for eligibility for this study 48 hours after initiation of treatment and considered for inclusion in the study if:
- 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 ( <35.5oC), high body temperature (=38oC), severe chest indrawing, fast breathing in <7 days old), and
- Laboratory test negative
1) Study-1: The Young Infant will be excluded if they have any of the following:
- Weight <2kg at the time of presentation (if age at screening is less than 10 days) or weight for age <-3z, or
- Appearance of low-mortality risk signs in first 24 hours of life, or
- Signs of critical illness (no movement at all, unable to feed at all, convulsions), or
- Signs of CSI associated with a high risk of mortality (stopped feeding well, movement only on stimulation, low body temperature < 35.5oC or two or more of the six signs of CSI), or
- 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
- Hospitalized for any illness in the previous 2 weeks, or
- Prior use of injectable antibiotics for the same illness, or
- Previously included in this study or currently included in any other study.
2) Study-2: The Young Infant will be excluded if they have any of the following:
- Weight <2kg at the time of presentation (if age at screening is less than 10 days) or weight-forage <-3z, or
- Signs of critical illness on admission (no movement at all, unable to feed at all, or convulsions), or
- Appearance of any high-mortality risk sign or multiple low-mortality risk signs in first 24 hours of life, or
- Hospitalized for any illness in the previous 2 weeks, or
- Prior use of injectable antibiotics for the same illness, or
- Previously included in this study or currently included in any other study, or
- Any other reason to stay in the hospital, as decided by the treating physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Death any time from randomization up to day 15 of initiation of therapy <br/ ><br>- Presence of any sign of critical illness (no movement at all, unable to feed at all, or convulsions) or any sign suggestive of another serious infection, e.g. meningitis, bone or joint infection at follow-up on specified time points <br/ ><br>- Presence of any new sign of CSI/ Critical illness at follow-up on specified timepoints. <br/ ><br>- Persistence of the presenting sign on day 8 of initiation of therapy.Timepoint: Study-1: <br/ ><br>Day 2, 4 or day 8 of initiation of therapy <br/ ><br>Study 2: <br/ ><br>Day 4 or day 8 of initiation of therapy
- Secondary Outcome Measures
Name Time Method oneTimepoint: None