Status and phase
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About
This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.
Enrollment
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Inclusion criteria
Exclusion criteria
If chest-indrawing observed at screening resolves after bronchodilator challenge, among those with wheeze at screening.
Severe respiratory distress (e.g., grunting, nasal flaring, head nodding, or severe chest-indrawing).
Presence of World Health Organization (WHO) Integrated Management of Childhood Illness (IMCI) danger signs including: lethargy or unconsciousness, convulsions, vomiting everything, or inability to drink or breastfeed.
Hypoxia (SaO2 < 90% on room air, as assessed by a Lifebox pulse oximeter).
Stridor when calm.
HIV-1 seropositivity or HIV-1 exposure, assessed as follows:
Severe acute malnutrition (i.e., weight for height/length < -3 SD, mid-upper arm circumference <115 mm, or edema).
Possible tuberculosis (coughing for more than 14 days).
Severe anemia, classified by WHO pocketbook guidelines (i.e., severe palmar pallor or hemoglobin <8.0 g/dL)
Severe malaria, classified by WHO pocketbook guidelines (e.g., positive malaria rapid diagnostic test (mRDT) with any danger sign, stiff neck, abnormal bleeding, clinical jaundice, or hemoglobinuria)
Known allergy to penicillin or amoxicillin.
Receipt of an antibiotic treatment in the 48 hours prior to the study based on caregiver's self-report and/or documentation in child's medical record.
Hospitalized within 14 days prior to the study.
Living outside Lilongwe urban area, the study catchment area.
Any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardize the child's health.
Any non-pneumonia acute medical illness which requires antibiotic treatment per local standard of care.
Participation in a clinical study of another investigational product within 12 weeks prior to randomization or planning to begin participation during this study.
Prior participation in an Innovative Treatments in Pneumonia (ITIP) study during a previous pneumonia diagnosis.
Primary purpose
Allocation
Interventional model
Masking
3,000 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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