Falciparum ParasitaemiaPhase 2NCT02488980
An Evaluation of Weekly Tafenoquine
A Phase 2 study testing Tafenoquine and Mefloquine in people with Falciparum Parasitaemia, run by U.S. Army Medical Research and Development Command.
Trial summary
This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Falciparum Parasitaemia
- What is being tested?
- Tafenoquine and Mefloquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Mar 2003
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences).
- Subjects aged 18-55 years.
- Subjects planning to reside in the study area for the entire study duration of approximately 70 weeks
Who cannot join
- Subjects with positive parasitaemia following halofantrine treatment for radical cure.
- Subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study.
- Subjects with personal or family history of seizures.
- Female subjects with a positive serum beta-HCG5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter).
- Women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant.
- Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. Subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines.
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- Subjects unwilling to report for drug administration or blood drawing during the 70 week duration of the study.
- Subjects with G6PD deficiency.
- Subjects with laboratory guideline values for exclusion: haemoglobin <10 gm/dL, platelets <80,000/mm3, WBC <3000ul3, creatinine or ALT more than twice the upper limit of normal for age.
- Subjects with an abnormal ECG, particularly an extended QTc interval > 0.42 seconds.
- Subjects taking any other anti-malarial product, or who had taken an antimalarial drug other than halofantrine within the previous two weeks.
- Subjects who had received an investigational drug (a new chemical entity not registered for use) within 30 days or 5 half-lives whichever was the longer.
- Subjects with a history of psychiatric disorder.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Evaluation of Weekly Tafenoquine (WR 238605/SB252263) Compared to Mefloquine for Chemosuppression of Plasmodium Falciparum in Western Kenya
This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.
Read the detailed description
Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended weekly follow-up safety visits until week 28.
- Conditions
- Falciparum Parasitaemia
- Being tested
- Tafenoquine, Mefloquine, Placebo
- Keywords
- Falciparum Parasitaemia, Malaria
- 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 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.
MefloquineDrug
Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.
PlaceboDrug
Placebo for three days followed by placebo once a week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tafenoquine | Experimental | Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks. Receives: Drug: Tafenoquine |
| Mefloquine | Active comparator | Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks. Receives: Drug: Mefloquine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prophylactic Outcome Defined by the Subject Having no Positive Smears
Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.
Measured: 24 Weeks
Secondary outcomes (2)
Protective Efficacy Based on Two Consecutive Positive Smears
Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. Analysis was based on a calculation of protective efficacy (PE) of tefaenoquine, defined as (1-relative risk of developing parasitaemia tafenoquine: placebo) x100% and 95.5% confidence intervals were constructed for the relative risk using Koopman's method.
Measured: 24 Weeks
Time to a Single Positive Smear
Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. 95.5% confidence intervals were constructed for the relative risk.
Measured: 24 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 startMay 2000
- Primary completionOct 2000
- Study completionMar 2003
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 (1)Papers the sponsor has linked to this study.
- Other trials for Falciparum ParasitaemiaStudies 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
- 306 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
- Jose Stoute, MD, Principal investigator, Penn State Hershey Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488980
- Sponsor's protocol ID
- A-9467
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2015
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: SmithKline Beecham
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 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Evaluation of Weekly Tafenoquine (WR 238605/SB252263) Compared to Mefloquine for Chemosuppression of Plasmodium Falciparum in Western Kenya
- ClinicalTrials.gov ID
- NCT02488980
- Acronym / sponsor ID
- A-9467
- Conditions
- Falciparum Parasitaemia
- Keywords
- Falciparum Parasitaemia, Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- SmithKline Beecham
- Study start
- May 2000
- Primary completion
- Oct 2000 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 24 Feb 2017
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 placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.
Detailed description
Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended weekly follow-up safety visits until week 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tafenoquine | Experimental | Drug: TafenoquineTafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks. |
| Mefloquine | Active comparator | Drug: MefloquineMefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences).
- Subjects aged 18-55 years.
- Subjects planning to reside in the study area for the entire study duration of approximately 70 weeks
Key exclusion criteria (13 listed)
- Subjects with positive parasitaemia following halofantrine treatment for radical cure.
- Subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study.
- Subjects with personal or family history of seizures.
- Female subjects with a positive serum beta-HCG5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter).
- Women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant.
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 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks. | Drug | Tafenoquine |
| MefloquineMefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks. | Drug | Mefloquine |
| PlaceboPlacebo for three days followed by placebo once a week for 24 weeks | Drug | Placebo |
Primary outcome
Prophylactic Outcome Defined by the Subject Having no Positive Smears
Time frame: 24 Weeks
Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.
2 secondary outcomes
Protective Efficacy Based on Two Consecutive Positive Smears
Time frame: 24 Weeks
Time to a Single Positive Smear
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: Yes. SmithKline Beecham
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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.
Jose Stoute, MD principal investigator
Penn State Hershey Infectious Diseases
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafenoquine and Mefloquine in people with Falciparum Parasitaemia, 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 13 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 30 May 2017. 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?
Yes. Results are posted in the registry (first posted 24 Feb 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?
Prophylactic Outcome Defined by the Subject Having no Positive Smears (time frame: 24 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 NCT02488980, 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 30 May 2017.