Chloroquine Population Pharmacokinetics in Pre and Post-partum Women

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Treatments: Chloroquine; Chloroquine diphosphate

Criteria

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