Phase 4
N=181
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT02389374 ↗Enrolled (actual)
181
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment — 0; 0; 0 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- chloroquine (Drug); Artemether-lumefantrine combination (Drug); Primaquine (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Menzies School of Health Research
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment |
0; 0; 0 | — |
| SECONDARY Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) |
0; 0; 0 | — |
| SECONDARY Fractional Change in Hb Between Baseline and Day 9 and 16 |
-2.3; -7.7; -13.8; -0.5; NA; -8.3 | — |
| SECONDARY Proportion of Patients With Anaemia Less Than 8g/dl on Day 2 |
0; 2; 0 | — |
| SECONDARY Proportion of Patients With Any Parasitemia on Day 3 After Treatment |
0; 2; 0 | — |
| SECONDARY Proportion of Patients With Fever on Day 2 After Treatment |
0; 0; 0 | — |
| SECONDARY Recurrence of Parasitaemia Within 16 Days of Follow up |
0; 0; 0 | — |
| SECONDARY Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count |
34; NA; 7 | — |
| SECONDARY The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients |
7.82 | — |
| SECONDARY Frequency and Type of Variants of the G6PD Gene Within the Study Population |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02389374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.