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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
Completed |
NCT02605720 -
Cardiac Safety of Repeated Doses of Dihydroartemisinin-Piperaquine for the Use in Mass Treatment Campaigns
|
Phase 3 |