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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| University of Washington | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 days amoxicillin + 2 days placebo | Experimental | 3 days amoxicillin DT + 2 days placebo DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age). |
|
| 5 days amoxicillin | Active Comparator | 5 days amoxicillin DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children failing treatment | 6 days |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Amy Ginsburg, MD, MPH | Save the Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bwaila District Hospital | Lilongwe | Malawi | ||||
| Kamuzu Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35241775 | Derived | Ginsburg AS, May S. Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi. Sci Rep. 2022 Mar 3;12(1):3538. doi: 10.1038/s41598-022-07582-w. | |
| 35012490 | Derived | Mvalo T, McCollum ED, Fitzgerald E, Kamthunzi P, Schmicker RH, May S, Phiri M, Chirombo C, Phiri A, Ginsburg AS. Chest radiography in children aged 2-59 months enrolled in the Innovative Treatments in Pneumonia (ITIP) project in Lilongwe Malawi: a secondary analysis. BMC Pediatr. 2022 Jan 10;22(1):31. doi: 10.1186/s12887-021-03091-3. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Placebo | Drug | Placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily |
|
| Lilongwe |
| Malawi |
| 32609979 | Derived | Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Phiri M, Schmicker R, Hwang J, Ndamala CB, Phiri A, Lufesi N, May S. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400. |
| 30241517 | Derived | Ginsburg AS, May SJ, Nkwopara E, Ambler G, McCollum ED, Mvalo T, Phiri A, Lufesi N, Sadruddin S. Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol. BMC Infect Dis. 2018 Sep 21;18(1):476. doi: 10.1186/s12879-018-3379-z. |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |