Vivax Malaria Clinical Trial
— KCPOfficial title:
The Population Pharmacokinetics of Chloroquine for the Treatment of Uncomplicated P.Vivax Malaria in Pre- and Post-partum Women.
NCT number | NCT01546961 |
Other study ID # | SMRU1003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2011 |
Est. completion date | May 2017 |
Verified date | January 2019 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body of evidence suggesting that pregnant women may require different doses of drugs, including antimalarials due to the physiological changes of pregnancy. It is important that any drug used in pregnant women it is given at the correct dose. The only way to evaluate this is by pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same evaluation in the same woman post-partum is required as a control.
Status | Completed |
Enrollment | 49 |
Est. completion date | May 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Age 18-50 years - Gestational age (ultrasound confirmed) > 13.0 weeks - Viable fetus as assessed by ultrasound scanning - Microscopically confirmed uncomplicated P.vivax malaria - Willingness and ability to comply with the study protocol for the duration of the trial - Written informed consent provided - No signs of labour Exclusion Criteria: - Known hypersensitivity to chloroquine - Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1 - Gastrointestinal dysfunction that could alter absorption or motility - History or known liver diseases or other chronic diseases (excluding thalassaemia & G6PD deficiency) - Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study - Splenectomy - Hematocrit (HCT) < 20% (based on field reading i.e. capillary sample) - Taking contraindicated medications - History of narcotic or alcohol abuse |
Country | Name | City | State |
---|---|---|---|
Thailand | Shoklo Malaria Research Unit | Tak | Mae Sot |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Population Pharmacokinetics of Chloroquine | Population pharmacokinetic parameters up to day 63 in pregnant women with uncomplicated P.vivax malaria, and in the same women post-partum with P.vivax or without P.vivax. | 63 days | |
Secondary | Relationship between pharmacokinetics and symptoms | Chloroquine pharmacokinetics versus symptomatology | 63 days | |
Secondary | Efficacy of Chloroquine | Chloroquine efficacy against P.vivax | 63 days | |
Secondary | Reticulocyte counts | Effect of chloroquine treatment on reticulocyte counts | 63 days | |
Secondary | Pregnancy outcomes | Pregnancy outcomes (abortions, low birth weight, premature birth, congenital abnormality, stillbirths, neonatal and infant mortality) | 63 days |
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