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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the effectiveness of whole blood transfusion to improve survival in children with severe malaria complicated by low platelet counts thrombocytopenia. This open-label randomized controlled trial involves children aged 6 months to under 5 years old who have severe malaria based on WHO criteria but do not currently require transfusion under existing guidelines. The study is part of a larger prospective observational cohort on severe malaria. Participants will be randomly assigned to one of two groups one group will receive a single whole blood transfusion at 20 mL per kilogram of body weight sourced from the Zambia National Blood Transfusion Service, while the other group will receive standard care without transfusion. Follow-up will continue until hospital discharge or death, with monitoring of various health parameters. During the study, children will undergo blood tests to measure hemoglobin, platelet count, and white blood cell count before transfusion and at 2 and 24 hours after transfusion, or at corresponding times for the control group. Researchers will track outcomes including mortality up to hospital discharge or death, transfusion reactions, length of hospital stay, and parasite clearance over 72 hours. The total participation period will last until discharge or in-hospital death, averaging up to 28 days.

Age: 6Months - 59MonthsAll GendersPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are studying treatment options for children under 10 years old who have drug-susceptible tuberculosis TB. The goal is to see if a shorter 2-month treatment regimen using isoniazid, rifapentine, pyrazinamide, and moxifloxacin is as safe and effective as the standard 4- to 6-month treatment regimen that uses isoniazid, rifampicin, pyrazinamide, and ethambutol. This study also looks at the safety of the shorter regimen in children with and without HIV. Participants will be randomly assigned to one of two treatment groups. One group will receive the standard regimen of 8 weeks of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 16 or 24 weeks of isoniazid and rifampin, depending on disease severity. The other group will receive 8 weeks of daily isoniazid, rifapentine, pyrazinamide, and moxifloxacin. All drugs are given once daily based on the participants weight. During the study, children will be monitored for TB disease-free survival up to 48 weeks after starting treatment and for adverse events over 28 weeks. Researchers will also assess treatment adherence, tolerability, drug levels, and the acceptability of the treatments reported by parents or guardians. Follow-up visits and evaluations will track health outcomes and safety throughout the study period, which lasts up to about 72 weeks from entry.

Age: 0Days - 9YearsAll GendersPhase 3
9 locations
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Actively Recruiting

Researchers are evaluating whether treating children with non-dysentery Shigella-associated watery diarrhea NDSD with antibiotics improves their clinical outcomes and growth. This study focuses on children aged 6 to 59 months who seek care for diarrhea at hospitals in Bangladesh and Zambia. It is a phase 2B, randomized, double-blind, placebo-controlled study aiming to address if antibiotic treatment benefits this group beyond current World Health Organization guidelines, which recommend antibiotics mainly for dysentery or cholera cases. Participants will be randomly assigned to receive either Azithromycin at a dose of 10 mgkg once daily for five days or a placebo that looks like the medication but contains no active drug. All children will receive standard rehydration therapy and zinc supplementation as part of routine care. Following treatment, children will be monitored for three months through household visits to track health outcomes and growth. During the study, researchers will assess the time it takes for diarrhea to stop and the time to clear the Shigella infection based on stool tests. They will also measure changes in weight-for-age and length-for-age scores over 90 days to evaluate growth. Data collection includes morbidity monitoring and anthropometric measurements. Safety and adherence to the study protocol will be observed throughout the follow-up period, which lasts about three months after enrollment.

Age: 6Months - 59MonthsAll GendersPhase 2
4 locations