Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan

NCT01178021 | Completed Phase 4

• 1 other identifier: BAKMAL0903
• Study Type: interventional
• Target: 593
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs. Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine

Conditions

Vivax Malaria

Keywords

malaria; vivax; relapse

Outcome Measures

Primary Outcomes (1)

• Secondary vivax attack

  Completion of the 1-year (± 1 month) follow-up period without secondary vivax attack

  1 year

Secondary Outcomes (6)

• secondary vivax attack

  6 months

• G6PD prevalence

  Time of enrollment

• Recurrence

  1 year

• Days of illness, haematocrit

  1 year

• Chloroquine levels

  Day 7

Study Arms (2)

Chloroquine

ACTIVE COMPARATOR

Standard arm

Drug: Chloroquine

Chloroquine/Primaquine

EXPERIMENTAL

Chloroquine combined with primaquine

Drug: Chloroquine/Primaquine

Interventions

Chloroquine DRUG

Chloroquine 10 mg/kg on day 0 \& 1 and 5mg/kg on day 2

Chloroquine

Chloroquine/Primaquine DRUG

Chloroquine 10 mg/kg on day 0 \& 1 and 5mg/kg on day 2 Primaquine (if given) 0.25mg/kg/day for 14 days

Chloroquine/Primaquine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults and children \>6 months
• Negative pregnancy test in women at risk of pregnancy
• Microscopic diagnosis of Plasmodium vivax mono-infection (\>200/µl asexual forms)
• Axillary temperature ≥37.5°C or oral/rectal temperature ≥38°C or history of fever within the last 24 hours
• Ability to swallow oral medication
• Participant (or parent/guardian if \<18 years old) is willing and able to give written informed consent
• Ability (in the investigator's opinion) and willingness of patient or parent/guardian to comply with all study requirements

You may not qualify if:

• Severe malaria (see WHO definition)
• Patients with microscopic diagnosis of co-infection with Plasmodium falciparum
• Haemoglobin concentration \<8g/dl
• Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study e.g. other acute febrile conditions or chronic disease
• Pregnancy or lactation
• History or phenotypic test compatible with severe G6PD deficiency
• History of hypersensitivity to any of the drugs being tested

Sponsors & Collaborators

• University of Oxford: lead
• National Malaria and Leishmaniasis Control Program, Afghanistan: collaborator
• Mahidol University: collaborator

Study Sites (3)

Provincial Malaria Control Centers (MRC)

Maymana, Faryab Province, Afghanistan

Location

Provincial Malaria Control Centers (MRC)

Jalalabad, Afghanistan

Location

Provincial Malaria Control Centers (MRC)

Kunduz, Afghanistan

Location

MeSH Terms

Conditions

Malaria, Vivax; Malaria; Recurrence

Interventions

Chloroquine; Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ghulam Rahim Awab, MD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 9, 2010
• Study Start: August 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

AF (3)