MedDataX Logo

Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria

NCT ID: NCT01784315

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parasitemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

The presence of parasites in the blood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Intervention Type DRUG

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

Chloroquine and Primaquine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Chloroquine and Primaquine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ACT Chloroquine(CQ) Primaquine (PQ)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asia Pacific Malaria Elimination Network

UNKNOWN

Sponsor Role collaborator

Menzies School of Health Research

OTHER

Sponsor Role collaborator

Ministry of Health, Bhutan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr.Yeshey Dorjey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr.Yeshey Dorjey

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Bhutan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vector Diseases Control Program, Gelephu

Geylegphug, Gelephu, Bhutan

Site Status NOT_YET_RECRUITING

Vector Diseases Control Program, Gelephu

Geylegphug, Gelephu, Bhutan

Site Status RECRUITING

Mr. Thinly

Sarpang, Sarpang District, Bhutan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Bhutan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr.Yeshey Dorjey

Role: CONTACT

Phone: 97517745239

Email: [email protected]

Dr.Kinley Penjor

Role: CONTACT

Phone: 97517619191

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr.Yeshey Dorjey

Role: primary

Dr.Kinley Penjor

Role: backup

Dr.Yeshey Dorjey

Role: primary

Dr.Kinley Penjor

Role: backup

Yeshey Dorjey, MBBS

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

http://www.apmen.org

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BCAPES

Identifier Type: -

Identifier Source: org_study_id