MalariaMPCNCT01624337
Malaria Prevention Cambodia
A study testing DHA-piperaquine in people with Malaria, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site in Cambodia.
Trial summary
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- DHA-piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteCambodia
- Study dates
- May 2012to Jun 2015
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer 18-65 years of age
- Able to give informed consent
- Likely to reside in malaria endemic area for the duration of the study
- Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
- Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
- Authorized by local commander to participate in the study if on active duty
Who cannot join
- Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
- Significant acute comorbidity requiring urgent medical intervention
- Positive malaria blood smear.
- Treatment with an antimalarial drug in the past 30 days.
- Pregnant or lactating female or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
- Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
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- Regular current use of known QTc prolonging medications
- History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
- Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.
Read the detailed description
This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.
- Conditions
- Malaria
- Being tested
- DHA-piperaquine, placebo
- Keywords
- Plasmodium falciparum, Plasmodium vivax
- Medical subject headings
- Malaria, Malaria, Falciparum, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA-piperaquineDrug
Also called Duocotexcin
Drug: Dihydroartemisinin piperaquine
40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day)
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| DHA-piperaquine | Experimental | DHA-piperaquine monthly 2 day treatment course Receives: Drug: DHA-piperaquine |
| Placebo | Placebo comparator | Matching placebo control Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective efficacy
To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo.
Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups.
Measured: 4 months
Secondary outcomes (1)
Cardiac safety of piperaquine as determined by QT interval prolongation
To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine.
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2014
- Study completionJun 2015
Why it stopped: Medication safety concern
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, Thailand
- Sponsor type
- Other government
- Collaborators
- National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Royal Cambodian Armed Forces, United States Army Medical Materiel Development Activity
- Responsible party
- Principal investigator, Philip Smith, Armed Forces Research Institute of Medical Sciences, Thailand
- Investigators
- DAVID SAUNDERS, MD, MPH, Principal investigator, Armed Forces Research Institute of Medical Sciences, ThailandChanthap Lon, MD, Principal investigator, Armed Forces Research Institute of Medical Sciences, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624337
- Sponsor's protocol ID
- WRAIR # 1849
- Other IDs
- A-17057
- Acronym
- MPC
- Status last verified
- Jul 2016
- First submitted
- 17 Jun 2012
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manning J, Vanachayangkul P, Lon C, Spring M, So M, Sea D, Se Y, Somethy S, Phann ST, Chann S, Sriwichai S, Buathong N, Kuntawunginn W, Mitprasat M, Siripokasupkul R, Teja-Isavadharm P, Soh E, Timmermans A, Lanteri C, Kaewkungwal J, Auayporn M, Tang D, Chour CM, Prom S, Haigney M, Cantilena L, Saunders D. Randomized, double-blind, placebo-controlled clinical trial of a two-day regimen of dihydroartemisinin-piperaquine for malaria prevention halted for concern over prolonged corrected QT interval. Antimicrob Agents Chemother. 2014 Oct;58(10):6056-67. doi: 10.1128/AAC.02667-14. Epub 2014 Aug 4.
PubMed 25092702Vanachayangkul P, Lon C, Spring M, Sok S, Ta-Aksorn W, Kodchakorn C, Pann ST, Chann S, Ittiverakul M, Sriwichai S, Buathong N, Kuntawunginn W, So M, Youdaline T, Milner E, Wojnarski M, Lanteri C, Manning J, Prom S, Haigney M, Cantilena L, Saunders D. Piperaquine Population Pharmacokinetics and Cardiac Safety in Cambodia. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02000-16. doi: 10.1128/AAC.02000-16. Print 2017 May.
PubMed 28193647
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.
- ClinicalTrials.gov ID
- NCT01624337
- Acronym / sponsor ID
- MPC / WRAIR # 1849
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, Plasmodium vivax
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medication safety concern
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, ThailandOther government
- Collaborators
- National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Royal Cambodian Armed Forces, United States Army Medical Materiel Development Activity
- Study start
- May 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Jun 2012 (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.
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.
Detailed description
This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA-piperaquine | Experimental | Drug: DHA-piperaquineDHA-piperaquine monthly 2 day treatment course |
| Placebo | Placebo comparator | Drug: placeboMatching placebo control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer 18-65 years of age
- Able to give informed consent
- Likely to reside in malaria endemic area for the duration of the study
- Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
- Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
Key exclusion criteria (9 listed)
- Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
- Significant acute comorbidity requiring urgent medical intervention
- Positive malaria blood smear.
- Treatment with an antimalarial drug in the past 30 days.
- Pregnant or lactating female or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
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 |
|---|---|---|
| DHA-piperaquineAlso: DuocotexcinDrug: Dihydroartemisinin piperaquine 40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day) | Drug | DHA-piperaquine |
| placebo | Drug | Placebo |
Primary outcome
Protective efficacy
Time frame: 4 months
To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo. Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups.
1 secondary outcome
Cardiac safety of piperaquine as determined by QT interval prolongation
Time frame: 4-5 months
Results and safety
The study was stopped early (reason given: Medication safety concern). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Background: PubMed 25092702Manning J, Vanachayangkul P, Lon C, Spring M, So M, Sea D, Se Y, Somethy S, Phann ST, Chann S, Sriwichai S, Buathong N, Kuntawunginn W, Mitprasat M, Siripokasupkul R, Teja-Isavadharm P, Soh E, Timmermans A, Lanteri C, Kaewkungwal J, Auayporn M, Tang D, Chour CM, Prom S, Haigney M, Cantilena L, Saunders D. Randomized, double-blind, placebo-controlled clinical trial of a two-day regimen of dihydroartemisinin-piperaquine for malaria prevention halted for concern over prolonged corrected QT interval. Antimicrob Agents Chemother. 2014 Oct;58(10):6056-67. doi: 10.1128/AAC.02667-14. Epub 2014 Aug 4.
- Derived from this study: PubMed 28193647Vanachayangkul P, Lon C, Spring M, Sok S, Ta-Aksorn W, Kodchakorn C, Pann ST, Chann S, Ittiverakul M, Sriwichai S, Buathong N, Kuntawunginn W, So M, Youdaline T, Milner E, Wojnarski M, Lanteri C, Manning J, Prom S, Haigney M, Cantilena L, Saunders D. Piperaquine Population Pharmacokinetics and Cardiac Safety in Cambodia. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02000-16. doi: 10.1128/AAC.02000-16. Print 2017 May.
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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.
DAVID SAUNDERS, MD, MPH principal investigator
Armed Forces Research Institute of Medical Sciences, Thailand
Chanthap Lon, MD principal investigator
Armed Forces Research Institute of Medical Sciences, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA-piperaquine in people with Malaria, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site in Cambodia.
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 9 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: stopped early, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Medication safety concern). Results are not available in the source record.
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?
Protective efficacy (time frame: 4 months). 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 NCT01624337, 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 12 Jul 2016.