BCAPES: Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria

Sponsor

Ministry of Health, Bhutan (Other)

Overall Status

Unknown status

CT.gov ID

NCT01784315

Collaborator

Asia Pacific Malaria Elimination Network (Other), Menzies School of Health Research (Other)

Enrollment

Locations

Duration (Months)

16.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research is intended to study the efficacy of CQ alone for P.vivax infection and also to study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone since masking effect over one another was found when CQ is given with PQ. So the investigators are not sure whether the recurrence is due to resistance to CQ or CQ concentration in blood is below therapeutic level or it is due to PQ is in inadequate dose. From this study the investigators will get findings like may be CQ is still working for P.vivax or no longer working for P.vivax due to resistance developed by P.vivax parasites. So for P.vivax which is not responding to CQ therapy, the investigators will go for second line treatment with ACT in a similar fashion as it is given for P. falciparum infection in Bhutan. And if the investigators find CQ is still working for P.vivax infection, the next level of study will be to compare higher dose of PQ with standard dose of PQ ( as practiced now) in lieu of bringing down the relapse rates in P. vivax infection.

Condition or Disease	Intervention/Treatment	Phase
Parasitemia	Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax Drug: Chloroquine and Primaquine

Detailed Description

In recent time in Bhutan P.vivax infection is on rise compared to other types of malaria like P.falciparum which used to be the most common infections. May be this is mainly due to intensive measures taken place in controlling the diseases especially vector control measures. So that way P.falciparum has gone now. But on other hand P.vivax has peaked the infection. The main reason could be due to resistant to Chloroquine or may be Chloroquine dose is inadequate, and it could also mean it could be due to relapses from the hypnozoites stage where Primaquine dose could be inadequate. Therefore this study is developed to study the efficacy of Chloroquine alone withholding Primaquine for day 28 slightly deviating from the current treatment protocol of Bhutan. That parasitic clearance and recurrence rates will be recorded while on Chloroquine and Primaquine separately. For those patients whose blood stage of parasites doesnt get cleared with standard dose of Chloroquine or for any recurrences occurring before day 28, will be treated with second line treatment with ACT, and the blood level of Chloroquine(drug concentration) will be determined to say whether that could be due to resistance or due to low level of Chloroquine in the blood. And for any recurrences occurring after day 28 while of Primaquine or after completion of Primaquine dosage for a total of 14 days (from day 29 to day 42) those patients will be treated in a similar fashion as initial treatment with Chloroquine and Primaquine and the recurrence rates will be recorded so as to develop next level of study where two different doses of Primaquine (high dose vs low dose) will be compared to study the efficacy of Primaquine.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Time Perspective:

Prospective

Official Title:

PARASITIC CLEARANCE AND RECURRENCE RATES AMONG PATIENTS WITH VIVAX MALARIA ON CHLOROQUINE AND PRIMAQUINE THERAPY

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Chloroquine, primaquine and ACT Standard dose of Chloroquine( 10mg/kg on day 0 and 5mg/kg on day1 and day2) and Primaquine(0.25mg/kg for 14 days). Artemisinin combination therapies (ACT) of 4 tablets on 0,8,24,36,48 and 60 hours will be used for Chloroquine resistant P.vivax infection	Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax 4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection. Other Names: ACT Drug: Chloroquine and Primaquine Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days. Other Names: Chloroquine(CQ) Primaquine (PQ)

Arm

Intervention/Treatment

Chloroquine, primaquine and ACT

Standard dose of Chloroquine( 10mg/kg on day 0 and 5mg/kg on day1 and day2) and Primaquine(0.25mg/kg for 14 days). Artemisinin combination therapies (ACT) of 4 tablets on 0,8,24,36,48 and 60 hours will be used for Chloroquine resistant P.vivax infection

Drug: Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax

4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection.

Other Names:

ACT

Drug: Chloroquine and Primaquine

Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days.

Other Names:

Chloroquine(CQ)

Primaquine (PQ)

Outcome Measures

Primary Outcome Measures

To measure recurrence rates among patients with vivax malarial infection put on standard dose of Chloroquine and Primaquine [12 months]
Patients with P.vivax mono-infection will be recruited for the study with a follow up for a period of 12 months. These patients will be put on standard dose of Chloroquine(10mg/Kg on day 0 and 5mg/kg on day 1, and 2) and Primaquine(0.25mg/kg)and any recurrence rates will be measured.

Secondary Outcome Measures

Genotyping of P.vivax strains in Bhutan. [12 months.]
One time venous blood samples will be collected from patients infected with mixed or mono-infection of P.vivax malaria. And the genotyping will be conducted to study the strains of P.vivax malaria that exist in Bhutan.

Other Outcome Measures

To measure Haemoglobin variations during the malarial infection with treatment. [12 months.]
Finger prick blood will be taken to check Haemoglobin levels on day 0,3, 7, 14, 28, 35, 42 and at the end of study(ie at the end of 12months).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age above 12months
infection with P.vivax
presence of axillary temperature >37.5 or history of fever during the past 24h
ability to swallow oral medication
ability and willingness to comply with the study protocol for the duration of the study ie 12 months follow up
informed consent from the patient/parent/guardian in the case of children

Exclusion Criteria:

signs and symptoms of severe or complicated malaria requiring parenteral treatment according to WHO criteria
severe malnutrition
febrile conditions caused by disease other than malaria or other known underlying chronic or severe diseases
regular medication which interferes with antimalarial pharmacokinetics
history of hypersensitivity reactions or contraindications to the medicine tested
positive pregnancy test or breastfeeding
unable to or unwilling to take contraceptives