MalariaPhase 2NCT02491606
Evaluation of Weekly Tafenoquine
A Phase 2 study testing Tafenoquine in people with Malaria, run by U.S. Army Medical Research and Development Command.
Trial summary
This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Malaria
- What is being tested?
- Tafenoquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- May 1997to Sep 1998
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects (male or female)
- Age of 18-55 years
- Residing in one of the study villages of the Nyanza Province for the entire study
Who cannot join
- Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
- Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
- Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
- Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
- Known hypersensitivity to any study drug.
- Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
- Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.
About this study
Official title: Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya
This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.
- Conditions
- Malaria
- Being tested
- Tafenoquine, Placebo
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafenoquineDrug
Tafenoquine 200mg and 400 mg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Load only | Experimental | Loading with tafenoquine 400 mg base for three days followed by placebo weekly. Receives: Drug: Tafenoquine |
| Low weekly dose | Experimental | Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly. Receives: Drug: Tafenoquine |
| High weekly dose | Experimental | Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly. Receives: Drug: Tafenoquine |
| Placebo | Experimental | Loading with placebo for 3 days followed by placebo once weekly. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prophylactic outcome.
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.
A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.
Measured: 13 Weeks
Secondary outcomes (2)
Prophylactic outcome after 7 weeks
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.
A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.
Measured: 7 Weeks
Prophylactic outcome after 10 weeks
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.
A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMay 1997
- Primary completionSep 1997
- Study completionSep 1998
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
- 249 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
- A.J Oloo, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491606
- Sponsor's protocol ID
- A-7540
- 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
- Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya
- ClinicalTrials.gov ID
- NCT02491606
- Acronym / sponsor ID
- A-7540
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- SmithKline Beecham
- Study start
- May 1997
- Primary completion
- Sep 1997 (actual)
- Study completion
- Sep 1998 (actual)
- First posted
- 8 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 study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Load only | Experimental | Drug: TafenoquineLoading with tafenoquine 400 mg base for three days followed by placebo weekly. |
| Low weekly dose | Experimental | Drug: TafenoquineLoading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly. |
| High weekly dose | Experimental | Drug: TafenoquineLoading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly. |
| Placebo | Experimental | Other: PlaceboLoading with placebo for 3 days followed by placebo once weekly. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects (male or female)
- Age of 18-55 years
- Residing in one of the study villages of the Nyanza Province for the entire study
Key exclusion criteria (7 listed)
- Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
- Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
- Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
- Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
- Known hypersensitivity to any study drug.
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 |
|---|---|---|
| TafenoquineTafenoquine 200mg and 400 mg | Drug | High weekly dose, Load only, Low weekly dose |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Prophylactic outcome.
Time frame: 13 Weeks
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.
2 secondary outcomes
Prophylactic outcome after 7 weeks
Time frame: 7 Weeks
Prophylactic outcome after 10 weeks
Time frame: 10 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.
A.J Oloo principal investigator
Kenya Medical Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafenoquine 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 7 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. 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?
Prophylactic outcome. (time frame: 13 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 NCT02491606, 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.