Vivax Malaria Clinical Trial
— VHCOfficial title:
Determining the Incidence of New Plasmodium Vivax Infections After Radical Treatment Following Vivax Malaria Along the Thai Burma Border
Verified date | October 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a continuous cohort study consisting of 200 participants (one third 6 months old to 5 years, one third 6 to 15 years old, one third ≥ 15 years old) i.e. a new patient will be recruited (from the same age group) for any patient who develops a Pv infection so that the cohort will always have 200 patients for 3 years. Each patient will be actively followed-up every 8 weeks until Plasmodium vivax infection occurs but the duration of follow up and the number of follow up visits for each patient will vary depending on when or if a vivax infection occurs and when the patient is recruited. Therefore, the minimum follow up period for each patient will be 6 months or time to vivax infection and the maximum will be 3 years if a patient does not get vivax infection and is recruited at the beginning of the study.
Status | Completed |
Enrollment | 403 |
Est. completion date | September 2, 2014 |
Est. primary completion date | September 2, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months and older |
Eligibility | Inclusion Criteria: - Asymptomatic adults and children = 6 months - Documented P.vivax infection in the last 12 months who have not received radical treatment with primaquine - Weight= 7 kg for children - Participant (or parent/guardian if <18 years old) is willing and able to give written informed consent - Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements Exclusion Criteria: - History of allergy to primaquine - Medical conditions such as known chronic diseases (TB, HIV, cardio vascular diseases), allergies, mental illnesses and similar conditions that could make the interpretation of symptoms or the follow up difficult. - Other conditions such as drug addiction, known poor compliance with treatment or follow up. - Inability to tolerate oral medication - Pregnancy - G6PD deficiency - Blood transfusion in the last 3 months - Microscopic evidence of Plasmodium vivax, P.falciparum, P. malariae or ovale - Fever =37.5C |
Country | Name | City | State |
---|---|---|---|
Thailand | Shoklo Malaria Research Unit | Mae Sot | Tak |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence | Incidence of primary infections with vivax malaria | Up to 3 years | |
Secondary | Adverse events | Adverse event profile of primaquine | Up to 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01625871 -
Artemether/Lumefantrine and Vivax Malaria
|
Phase 3 | |
Completed |
NCT02876549 -
G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria
|
Phase 4 | |
Completed |
NCT01218932 -
Pharmacokinetic Study of Primaquine and Chloroquine in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04228315 -
Biomarkers of P. Vivax Relapse
|
N/A | |
Completed |
NCT02118090 -
Assessment of Plasmodium Vivax Chloroquine Resistance in Cambodia:
|
Phase 4 | |
Completed |
NCT01074905 -
Study on the Treatment of Vivax Malaria
|
Phase 3 | |
Completed |
NCT04222088 -
TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
|
||
Completed |
NCT01546961 -
Chloroquine Population Pharmacokinetics in Pre and Post-partum Women
|
N/A | |
Completed |
NCT00158548 -
ACT With Chloroquine, Amodiaquine & Sulphadoxine-pyrimethamine in Pakistan
|
Phase 3 | |
Completed |
NCT00682578 -
A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan
|
Phase 3 | |
Completed |
NCT00157833 -
A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.
|
N/A | |
Active, not recruiting |
NCT03529396 -
Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients
|
Phase 2 | |
Recruiting |
NCT05874271 -
Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea
|
N/A | |
Completed |
NCT05958797 -
TES of Chloroquine for Pv in the Philippines in 2016
|
||
Completed |
NCT01716260 -
Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan
|
N/A | |
Completed |
NCT01288820 -
Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria
|
Phase 3 | |
Completed |
NCT01640574 -
Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD)
|
Phase 3 | |
Completed |
NCT00158561 -
Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria
|
Phase 3 | |
Completed |
NCT01780753 -
Primaquine Pharmacokinetics in Lactating Women and Their Infants
|
Phase 1 | |
Completed |
NCT06044805 -
Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
|
Phase 4 |