MalariaPhase 2NCT02488902
A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum
A Phase 2 study testing Tafenoquine 25mg, Tafenoquine 50mg and Tafenoquine 100 mg in people with Malaria, run by U.S. Army Medical Research and Development Command.
Trial summary
This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Tafenoquine 25mg, Tafenoquine 50mg and Tafenoquine 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 521 participants
- Where
- No sites listed yet
- Study dates
- Aug 1998to Mar 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing subjects in good general health.
- Males aged 18 to 60; females aged 50 to 60.
- Subjects who planned to stay in the study area until the end of the study.
Who cannot join
- Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.
- Subjects with a personal or family history of seizures or frank psychiatric disorder.
- Females who had not ceased menstruation; a urine β-human chorionic gonadotrophin (β-HCG) test was to be performed at screening females who had ceased menstruation to exclude pregnancy as a cause.
- Females who were lactating.
- Subjects given antimalarial drugs for treatment within two weeks of study drug initiation.
- Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistry and haematology values.
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- Subjects with known hypersensitivity to any of the study drugs.
- Subjects unwilling to remain in the area, report for drug administration or blood drawing during the 3-4 month duration of the study.
- Subjects with G6PD deficiency (as determined by two separate qualitative tests per subject administered using distinct methods; methods used were visual dye and filter paper methods).
- Subjects with any of the following laboratory values: haemoglobin (Hb) <8g/dL, platelets <80,000/mm3, white blood cell count (WBC) <3000/mm3, creatinine >1.5mg/dL, alanine transaminase (ALT) >60IU or 1+ haematuria as detected by urine dipstick.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum in Semi-immune Adults Living in the Kassena-Nankana District of Northern Ghana
This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.
- Conditions
- Malaria
- Being tested
- Placebo, Tafenoquine 25mg, Tafenoquine 50mg, Tafenoquine 100 mg, Tafenoquine 200 mg
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
Tafenoquine 25mgDrug
Tafenoquine 25mg
Tafenoquine 50mgDrug
Tafenoquine 50mg
Tafenoquine 100 mgDrug
Tafenoquine 100 mg
Tafenoquine 200 mgDrug
Tafenoquine 200 mg
Mefloquine 250 mgDrug
Mefloquine 250 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. Receives: Drug: Placebo |
| Tafenoquine 25mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. Receives: Drug: Tafenoquine 25mg |
| Tafenoquine 50mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. Receives: Drug: Tafenoquine 50mg |
| Tafenoquine 100 mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. Receives: Drug: Tafenoquine 100 mg |
| Tafenoquine 200 mg | Experimental | Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. Receives: Drug: Tafenoquine 200 mg |
| Mefloquine 250 mg | Experimental | Mefloquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. Receives: Drug: Mefloquine 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of malaria infection
First occurrence of malaria infection as documented by a positive malaria smear.
Measured: 16 weeks
Secondary outcomes (1)
Time to confirmation of parasitaemia
Time to confirmation of parasitaemia as documented by two consecutive positive smears and the incidence density of parasitaemia.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startAug 1998
- Primary completionSep 1998
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- SmithKline Beecham
- Responsible party
- Sponsor
- Investigators
- Braden Hale, MD, Principal investigator, US Naval Medical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488902
- Sponsor's protocol ID
- A-8340
- Status last verified
- Sep 2018
- First submitted
- 30 Jun 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8.
PubMed 28495354
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum in Semi-immune Adults Living in the Kassena-Nankana District of Northern Ghana
- ClinicalTrials.gov ID
- NCT02488902
- Acronym / sponsor ID
- A-8340
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- SmithKline Beecham
- Study start
- Aug 1998
- Primary completion
- Sep 1998 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
| Tafenoquine 25mg | Experimental | Drug: Tafenoquine 25mgTafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
| Tafenoquine 50mg | Experimental | Drug: Tafenoquine 50mgTafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
| Tafenoquine 100 mg | Experimental | Drug: Tafenoquine 100 mgTafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
| Tafenoquine 200 mg | Experimental | Drug: Tafenoquine 200 mgTafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
| Mefloquine 250 mg | Experimental | Drug: Mefloquine 250 mgMefloquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing subjects in good general health.
Key exclusion criteria (10 listed)
- Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| Tafenoquine 25mgTafenoquine 25mg | Drug | Tafenoquine 25mg |
| Tafenoquine 50mgTafenoquine 50mg | Drug | Tafenoquine 50mg |
| Tafenoquine 100 mgTafenoquine 100 mg | Drug | Tafenoquine 100 mg |
| Tafenoquine 200 mgTafenoquine 200 mg | Drug | Tafenoquine 200 mg |
| Mefloquine 250 mgMefloquine 250 mg | Drug | Mefloquine 250 mg |
Primary outcome
First occurrence of malaria infection
Time frame: 16 weeks
First occurrence of malaria infection as documented by a positive malaria smear.
1 secondary outcome
Time to confirmation of parasitaemia
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Derived from this study: PubMed 28495354Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8.
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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.
Braden Hale, MD principal investigator
US Naval Medical Research Unit
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafenoquine 25mg, Tafenoquine 50mg and Tafenoquine 100 mg in people with Malaria, run by U.S. Army Medical Research and Development Command.
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 3 inclusion and 10 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 Sep 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First occurrence of malaria infection (time frame: 16 weeks). 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 NCT02488902, which also lists 1 linked publication.
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 Sep 2018.