Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 is given at the correct dose. The only way to evaluate this is by pharmacokinetic studies. We 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.

The two most recent pharmacokinetic publications conclude differently on chloroquine dosing in pregnant women: one suggests no dose adjustment and the other that a higher dose is probably needed. It is crucial that pregnant women are dosed correctly to maximise cure and minimize the chance for recurrence and the harmful effects of malaria. The proposed study on the pharmacokinetics of chloroquine treatment in pregnant women will solve this dilemma.

Pregnant women on the Thai-Burmese border are encouraged to attend antenatal care often for early detection and treatment of malaria. Low birth weight due to P.vivax affects primigravida and multigravida, not just primarily primigravida as with P.falciparum(highlighted in the attached reference). Hence it is important to consider these women for radical cure. This is not possible during pregnancy as primaquine is contraindicated so the next best time is in the post-partum period. During the post-partum period the woman remains in close contact with midwives for infant care and for their personal health. The midwives also have a record of malaria attacks during pregnancy.

We know more about chloroquine than any other antimalarial used in pregnancy. It has been widely used for prevention and treatment of malaria in pregnancy and in women with autoimmune disease such systemic lupus and rheumatoid arthritis high doses of hydroxychloroquine have been given daily including during the first trimester of pregnancy. Although data from prospective clinical trials of malaria are limited, this drug is considered safe in all trimester of pregnancy and in lactation.

For treatment of uncomplicated P.vivax WHO recommends chloroquine and primaquine where P.vivax remains chloroquine sensitive. A 14 day course of primaquine is recommended for radical cure of P.vivax. WHO advises not to use primaquine during pregnancy or in severe G6PD. WHO permits the use of primaquine during lactation if the breast fed infant is not G6PD deficient.

The possibility that women with recurrent P.vivax in the same pregnancy may have chloroquine resistant P.vivax needs to be considered. While the combination of chloroquine and primaquine cannot be used in pregnancy and the safety and efficacy of ACTs are still undergoing evaluation we need to explore alternatives to chloroquine for such cases. ACTs are recommended for chloroquine resistant P.vivax by WHO and one ACT considered safe in pregnancy and lactation is a 7 day course of artesunate-clindamycin. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01546961
Study type Interventional
Source University of Oxford
Contact
Status Completed
Phase N/A
Start date June 2011
Completion date May 2017

See also
  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 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 NCT01076868 - Incidence of Vivax Along the Thai Burma Border N/A
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