Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone.
This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.
| Condition | Intervention |
|---|---|
|
Vivax Malaria |
Drug: Chloroquine Drug: Primaquine |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy |
- Chloroquine efficacy for P.vivax infections in Bhutan. [ Time Frame: 28 days ] [ Designated as safety issue: No ]The purpose is to study the efficacy of Chloroquine alone by recording recrudescent rates and parasitic clearance in P.vivax patients who are given a standard dose of Chloroquine treatment.
- To study the efficacy of Primaquine. [ Time Frame: Patients with recurrence after day 28 will be recorded. ] [ Designated as safety issue: Yes ]In this study, Primaquine will be administered on day 28, and any relapse will be recorded to study relapse rates over a 12 month period.
- To assess the feasibility of a 12 month follow-up of patients with vivax malaria in Bhutan. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To assess the safety of the currently prescribed CQ and PQ regimens in Bhutan. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Chloroquine and Primaquine
Chloroquine (CQ)10mg/kg for day 1, 2 and 5mg/kg for day 3 Primaquine (PQ)0.25mg/kg/day for 14 days
|
Drug: Chloroquine Drug: Primaquine |
Detailed Description:
This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day 28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of parasites are not cleared with the standard dose of Chloroquine, or any recurrences before day 28, will be treated with second line treatment (ACT).
The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent infection will de determined to assess whether that could be due to resistance, or due to low level of Chloroquine.
Any relapses occurring after day 28 when not receiving Primaquine, or after completion of Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat doses of the initial treatment. The recurrence rates will be recorded so as to develop the next phase of the study where the two different doses of Primaquine (high dose vs. low dose) will be compared.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with P.vivax infections will be recruited from 6 sentinel sites and will be recruited for the study after informed consent is received.
Inclusion Criteria:
- >12 months of age
- infection with P.vivax parasitaemia monoinfection
- presence of axillary temperature >37.5 degrees or history of fever during the past 24 hours
- ability to swallow oral medication
- ability and willingness to comply with the study protocol for the duration of the study, including 12 months follow up
- informed consent from the patient/parent/guardian in the case of children
Exclusion Criteria:
- Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
- Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
- History of haemolysis or severe anaemia
- Acute anaemia <7 mg/dL
- Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- Regular medication, which may interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
- a positive pregnancy test or lactating
Contacts and Locations| Contact: Dr Lorenz von Seidlein, MD | +61 8 8922 6998 |
| Bhutan | |
| Vector Diseases Control Program | Not yet recruiting |
| Gelephu, Bhutan | |
| Contact: Dr Yeshey Dorjey, MD | |
| Contact: Dr Kinley Penjor, MD | |
| Principal Investigator: Dr Yeshey Dorjey | |
| Sub-Investigator: Dr Kinley Penjor | |
| Sub-Investigator: Dr Tashi Peldon | |
| Sub-Investigator: Mr Tobgay Tobgay | |
| Sub-Investigator: Dr Lorenz von Seidlein | |
More Information
No publications provided
| Responsible Party: | Menzies School of Health Research |
| ClinicalTrials.gov Identifier: | NCT01716260 History of Changes |
| Other Study ID Numbers: | Bhutan_APMEN_CQ PQ_2013 |
| Study First Received: | October 25, 2012 |
| Last Updated: | October 26, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Additional relevant MeSH terms:
|
Malaria Malaria, Vivax Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Primaquine Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013