Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

NCT01716260 | Completed DMC

• 1 other identifier: Bhutan_APMEN_CQ PQ_2013
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vivax Malaria

Outcome Measures

Primary Outcomes (1)

• Chloroquine efficacy for P.vivax infections in Bhutan.

  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.

  28 days

Secondary Outcomes (1)

• To study the efficacy of Primaquine.

  Patients with recurrence after day 28 will be recorded.

Other Outcomes (2)

• To assess the feasibility of a 12 month follow-up of patients with vivax malaria in Bhutan.

  12 months

• To assess the safety of the currently prescribed CQ and PQ regimens in Bhutan.

  12 months

Study Arms (1)

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

Interventions

Chloroquine DRUG

Chloroquine and Primaquine

Primaquine DRUG

Chloroquine and Primaquine

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with P.vivax infections will be recruited from 6 sentinel sites and will be recruited for the study after informed consent is received. An amendment has been approved to extend the study to 12 sites.

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menzies School of Health Research: lead
• Ministry of Health, Bhutan: collaborator

Study Sites (1)

Vector Diseases Control Program

Geylegphug, Bhutan

Location

MeSH Terms

Conditions

Malaria, Vivax

Interventions

Chloroquine; Primaquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 27, 2016

Record last verified: 2015-04

Locations

BH (1)