Incidence of Vivax Along the Thai Burma Border

NCT01076868 | Completed

• 1 other identifier: SMRU0909
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

This is a continuous cohort study consisting of 200 participants (one third 6 months old to 5 years, one third 6 to 15 years old, one third ≥ 15 years old) i.e. a new patient will be recruited (from the same age group) for any patient who develops a Pv infection so that the cohort will always have 200 patients for 3 years. Each patient will be actively followed-up every 8 weeks until Plasmodium vivax infection occurs but the duration of follow up and the number of follow up visits for each patient will vary depending on when or if a vivax infection occurs and when the patient is recruited. Therefore, the minimum follow up period for each patient will be 6 months or time to vivax infection and the maximum will be 3 years if a patient does not get vivax infection and is recruited at the beginning of the study.

Conditions

Vivax Malaria

Keywords

vivax; malaria; relapse

Outcome Measures

Primary Outcomes (1)

• Incidence

  Incidence of primary infections with vivax malaria

  Up to 3 years

Secondary Outcomes (1)

• Adverse events

  Up to 3 years

Study Arms (1)

Primaquine

EXPERIMENTAL

Primaquine 14 days

Drug: Primaquine

Interventions

Primaquine DRUG

Primaquine x 14 days

Also known as: primaquine 0.5 mg/kg/day

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:

• Asymptomatic adults and children ≥ 6 months
• Documented P.vivax infection in the last 12 months who have not received radical treatment with primaquine
• Weight≥ 7 kg for children
• Participant (or parent/guardian if \<18 years old) is willing and able to give written informed consent
• Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements

You may not qualify if:

• History of allergy to primaquine
• Medical conditions such as known chronic diseases (TB, HIV, cardio vascular diseases), allergies, mental illnesses and similar conditions that could make the interpretation of symptoms or the follow up difficult.
• Other conditions such as drug addiction, known poor compliance with treatment or follow up.
• Inability to tolerate oral medication
• Pregnancy
• G6PD deficiency
• Blood transfusion in the last 3 months
• Microscopic evidence of Plasmodium vivax, P.falciparum, P. malariae or ovale
• Fever ≥37.5C

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol University: collaborator

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, Thailand

Location

MeSH Terms

Conditions

Malaria, Vivax; Malaria; Recurrence

Interventions

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

• Francois Nosten, MD

  Shoklo Malaria Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: February 1, 2010
• Primary Completion: September 2, 2014
• Study Completion: September 2, 2014
• Last Updated: January 17, 2023

Record last verified: 2018-10

Locations

TH (1)