CompletedPhase 4

A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh

181 participantsStarted 2014-08

Plain-language summary

This is a study assessing safety and efficacy of current national guidelines for the treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among the enrolled patients.

Who can participate

Age range

12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 12 months * P. vivax or P. falciparum monoinfection or P.v. / P.f. mixed infection * Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs * Ability to swallow oral medication. * Ability and willingness to comply with the study protocol for the duration of the study * Informed consent/assent from the patient or from a parent or 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 * Acute anaemia \<8g/dL * Regular medication, which may interfere with antimalarial pharmacokinetics * History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s) * A positive pregnancy test or lactating

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment

Timeframe: during follow up (day 28)

Trial details

NCT IDNCT02389374

SponsorMenzies School of Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2017-01-31

View on ClinicalTrials.gov More Malaria trials

Who can participate

Age range

12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.