MalariaPhase 4NCT02389374
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
A Phase 4 study testing chloroquine, Artemether-lumefantrine combination and Primaquine in people with Malaria, run by Menzies School of Health Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Malaria
- What is being tested?
- chloroquine, Artemether-lumefantrine combination and Primaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Mar 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh
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.
Read the detailed description
The national guidelines for the treatment of uncomplicated malaria in Bangladesh currently recommend a standard dose of artemether-lumefantrine followed by a single dose of primaquine for P. falciparum malaria and a three day course of chloroquine followed by 14 days of primaquine for vivax malaria.Currently the national treatment guidelines do not include any testing for G6PD deficiency before treatment with primaquine. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in Bangladesh, it is essential to monitor the effectiveness and safety of the recommended treatment guidelines. This trial therefore evaluates the local efficacy and safety of the current first line treatment and assesses the G6PD status of the enrolled patients.
Patients with uncomplicated malaria attending the health care center, who meet the study inclusion criteria will be enrolled, treated on site and followed up for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. The study will provide efficacy data for both artemether-lumefantrine and chloroquine and will generate data on G6PD status in the region, which will provide vital information for policy makers in regards to the wider roll out of primaquine for the radical cure of vivax malaria.
- Conditions
- Malaria
- Being tested
- chloroquine, Artemether-lumefantrine combination, Primaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroquineDrug
standard dose
Artemether-lumefantrine combinationDrug
standard dose
PrimaquineDrug
single dose
PrimaquineDrug
14 days
| Study group | Role | What they receive |
|---|---|---|
| chloroquine primaquine 14days | Other | P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines Receives: Drug: chloroquine; Drug: Primaquine |
| artemether-lumefantrine primaquine 1day | Other | P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines Receives: Drug: Artemether-lumefantrine combination; Drug: Primaquine |
| artemether-lumefantrine primaquine 14days | Other | mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines Receives: Drug: Artemether-lumefantrine combination; Drug: Primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28
Measured: during follow up (day 28)
Secondary outcomes (9)
Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)
Measured: day 28
Fractional Change in Hb Between Baseline and Day 9 and 16
Measured: day 0 and 16
Proportion of Patients With Anaemia Less Than 8g/dl on Day 2
Measured: on day 2
Proportion of Patients With Any Parasitemia on Day 3 After Treatment
Measured: day 3
Proportion of Patients With Fever on Day 2 After Treatment
Measured: day 2
Recurrence of Parasitaemia Within 16 Days of Follow up
Measured: day 16
Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count
Measured: day 16
The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients
Measured: day 0
Frequency and Type of Variants of the G6PD Gene Within the Study Population
Frequency and type of variants of the G6PD gene within the study population
Measured: day 0 or 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389374
- Sponsor's protocol ID
- PR-14053
- Status last verified
- Mar 2024
- First submitted
- 5 Feb 2015
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Alam MS, Ley B, Nima MK, Johora FT, Hossain ME, Thriemer K, Auburn S, Marfurt J, Price RN, Khan WA. Molecular analysis demonstrates high prevalence of chloroquine resistance but no evidence of artemisinin resistance in Plasmodium falciparum in the Chittagong Hill Tracts of Bangladesh. Malar J. 2017 Aug 15;16(1):335. doi: 10.1186/s12936-017-1995-5.
PubMed 28806961Ley B, Alam MS, Thriemer K, Hossain MS, Kibria MG, Auburn S, Poirot E, Price RN, Khan WA. G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study. PLoS One. 2016 Apr 29;11(4):e0154015. doi: 10.1371/journal.pone.0154015. eCollection 2016.
PubMed 27128675
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh
- ClinicalTrials.gov ID
- NCT02389374
- Acronym / sponsor ID
- PR-14053
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The national guidelines for the treatment of uncomplicated malaria in Bangladesh currently recommend a standard dose of artemether-lumefantrine followed by a single dose of primaquine for P. falciparum malaria and a three day course of chloroquine followed by 14 days of primaquine for vivax malaria.Currently the national treatment guidelines do not include any testing for G6PD deficiency before treatment with primaquine. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in Bangladesh, it is essential to monitor the effectiveness and safety of the recommended treatment guidelines. This trial therefore evaluates the local efficacy and safety of the current first line treatment and assesses the G6PD status of the enrolled patients.
Patients with uncomplicated malaria attending the health care center, who meet the study inclusion criteria will be enrolled, treated on site and followed up for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. The study will provide efficacy data for both artemether-lumefantrine and chloroquine and will generate data on G6PD status in the region, which will provide vital information for policy makers in regards to the wider roll out of primaquine for the radical cure of vivax malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chloroquine primaquine 14days | Other | Drug: chloroquine, Drug: PrimaquineP.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines |
| artemether-lumefantrine primaquine 1day | Other | Drug: Artemether-lumefantrine combination, Drug: PrimaquineP.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines |
| artemether-lumefantrine primaquine 14days | Other | Drug: Artemether-lumefantrine combination, Drug: Primaquinemixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chloroquinestandard dose | Drug | chloroquine primaquine 14days |
| Artemether-lumefantrine combinationstandard dose | Drug | artemether-lumefantrine primaquine 14days, artemether-lumefantrine primaquine 1day |
| Primaquinesingle dose | Drug | artemether-lumefantrine primaquine 1day |
| Primaquine14 days | Drug | artemether-lumefantrine primaquine 14days, chloroquine primaquine 14days |
Primary outcome
The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
Time frame: during follow up (day 28)
The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28
9 secondary outcomes
Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)
Time frame: day 28
Fractional Change in Hb Between Baseline and Day 9 and 16
Time frame: day 0 and 16
Proportion of Patients With Anaemia Less Than 8g/dl on Day 2
Time frame: on day 2
Proportion of Patients With Any Parasitemia on Day 3 After Treatment
Time frame: day 3
Proportion of Patients With Fever on Day 2 After Treatment
Time frame: day 2
Recurrence of Parasitaemia Within 16 Days of Follow up
Time frame: day 16
Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count
Time frame: day 16
The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients
Time frame: day 0
Frequency and Type of Variants of the G6PD Gene Within the Study Population
Time frame: day 0 or 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28806961Alam MS, Ley B, Nima MK, Johora FT, Hossain ME, Thriemer K, Auburn S, Marfurt J, Price RN, Khan WA. Molecular analysis demonstrates high prevalence of chloroquine resistance but no evidence of artemisinin resistance in Plasmodium falciparum in the Chittagong Hill Tracts of Bangladesh. Malar J. 2017 Aug 15;16(1):335. doi: 10.1186/s12936-017-1995-5.
- Derived from this study: PubMed 27128675Ley B, Alam MS, Thriemer K, Hossain MS, Kibria MG, Auburn S, Poirot E, Price RN, Khan WA. G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study. PLoS One. 2016 Apr 29;11(4):e0154015. doi: 10.1371/journal.pone.0154015. eCollection 2016.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chloroquine, Artemether-lumefantrine combination and Primaquine in people with Malaria, run by Menzies School of Health Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment (time frame: during follow up (day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.