Malaria Clinical Trial
— NOHARMOfficial title:
Novel Use Of Hydroxyurea in an African Region With Malaria
Verified date | November 2018 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute
painful episodes and reducing the need for blood transfusions in children with sickle cell
anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan
Africa, the areas with the most children with SCA.
The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for
children with SCA in a malaria endemic region within sub-Saharan Africa.
Status | Completed |
Enrollment | 208 |
Est. completion date | November 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 47 Months |
Eligibility |
Inclusion Criteria: - Pediatric subjects with documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis or by peripheral blood smear showing sickled red blood cells) - Age range of 1.00-3.99 years, inclusive, at the time of enrollment - Weight at least 5.0 kg at the time of enrollment - Willingness to comply with all study-related treatments, evaluations, and follow up Exclusion Criteria: - Known chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis) - Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or weight-for-length/height > 3 z-scores below the median WHO growth standards) - Pre-existing severe hematological toxicity: 1. Hb <4.0 g/dL 2. Hb <6.0 g/dL AND ARC <100 x 10E9/L 3. Hb <7.0 g/dL AND ARC <80 x 10E9/L 4. Platelets <80 x 10E9/L 5. ANC <1.0 x 10E9/L - Alanine transaminase (ALT) or creatinine >2 times the upper limit of normal for age - Blood transfusion within 30 days prior to enrollment |
Country | Name | City | State |
---|---|---|---|
Uganda | Mulago Hospital Sickle Cell Clinic | Kampala |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Children's Hospital Medical Center, Cincinnati, Doris Duke Charitable Foundation, Makerere University, Mulago Hospital, Uganda |
Uganda,
Opoka RO, Ndugwa CM, Latham TS, Lane A, Hume HA, Kasirye P, Hodges JS, Ware RE, John CC. Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM): a trial for children with sickle cell anemia. Blood. 2017 Dec 14;130(24):2585-2593. doi: 10.1182/ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Malaria Episodes | Malaria is defined as the presence of P. falciparum or P. malariae on the peripheral smear of any child brought in for medical evaluation of fever. P. vivax, P. ovale and P. knowlesi are not known to be present in this region, but if a child is seen with suspected infection with any of these malaria parasites, this will also be recorded as a case of malaria. Incidence will be reported in the number of cases per 100 patient years. | 12 months |
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