Plasmodium Falciparum Malaria (Drug Resistant)Phase 4APACTNCT03726593
Drug Combinations of Atovaquone-Proguanil (AP) With ACT
A Phase 4 study testing Artesunate and Pyronaridine, Atovaquone Proguanil and Artesunate Pyronaridine and Atovaquone Proguanil and Artesunate Mefloquine in people with Plasmodium Falciparum Malaria (Drug Resistant), run by Armed Forces Research Institute of Medical Sciences, Thailand at 3 sites in Cambodia.
Trial summary
Investigators are conducting this study due to recent reports of many of existing malaria drugs becoming less effective for treatment of malaria. The drugs may not always kill all the parasites, therefore not all patients with malaria are being cured. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plasmodium Falciparum Malaria (Drug Resistant)
- What is being tested?
- Artesunate and Pyronaridine, Atovaquone Proguanil and Artesunate Pyronaridine and Atovaquone Proguanil and Artesunate Mefloquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 3 sitesCambodia
- Study dates
- 4 Oct 2018to 30 Dec 2022
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands Khmer spoken language
- Male or female (18 to 70 years old)
- Microscopic confirmation of asexual stages of Pf or mixed infection with Pf, with baseline asexual parasite densities between 100/µL to 200,000/µL
- Able to take oral medications
- Hemoglobin on day of enrollment ≥9.0 g/dL
- Agree to follow-up for the anticipated study duration, including a minimum of 3 nights at the medical treatment facility (inpatient hospitalization) and weekly follow-up visits for at least 6 weeks
- If the volunteer is on active duty in the military, the volunteer has written permission from their supervisor or states to have been authorized by his/her supervisor or the local commander to participate; and allow study staff to contact their supervisor to confirm this information
Who cannot join
- Known allergic reaction to any of the study drugs or history of severe intolerance to any of the antimalarials used in this study.
- Pregnant or lactating females and females of childbearing potential who do not agree to use an acceptable form of contraception during the study period and for 6 weeks following the last dose of the study drug.
- Symptoms of severe vomiting (inability to tolerate oral fluids or oral medications during the previous 8 hours or vomiting >3 times in the last 24 hrs).
- Diagnosis of severe malaria
- Abnormal liver function tests i.e AST or ALT or total bilirubin > 1.5 upper limit of normal (ULN) with nausea AND right upper quadrant abdominal pain OR jaundice on exam
- Isolated AST or ALT or Total Bilirubin >2x ULN
Show all 10Show fewer
- Known significant cardiovascular, liver or renal abnormality or any other clinically significant illness, which in the opinion of the investigator would place the volunteer at significantly higher risk
- Treatment for malaria within the last 4 weeks
- Unable to provide informed consent
- Judged by the investigator to be otherwise unsuitable for study participation (to include, but not limited to, taking other medications that are known to cause serious drug-drug interactions with the study drugs, as determined by the study physician, or having suspected medical condition or taking other drugs that may affect test results interpretation or put the volunteer at much higher risk)
Trial locations and contacts
3 sites in 1 country.
Cambodia3 sites, 3 recruiting
- Recruiting
Anlong Veng Referral Hospital
Anlong Veaeng
Phan Kong, M.A, 016 51 09 09
Chanthap Lon, MD
- Recruiting
Kratie Referral Hospital
Kratie
Somaly Kieng, M.D, +855 72 971 755
Chanthap Lon, M.D, 855 23 881 845, chanthapl@afrims.org
- Not yet recruiting
Stung Treng Referral Hospital
Stung Treng
Dysoley Lek, MD
About this study
Official title: Multicenter Therapeutic Efficacy Assessment of Pyronaridine-Artesunate (Pyramax®) and New Drug Combinations With Atovaquone-Proguanil for the Treatment of Uncomplicated P. Falciparum Malaria in Cambodia
Investigators are conducting this study due to recent reports of many of existing malaria drugs becoming less effective for treatment of malaria. The drugs may not always kill all the parasites, therefore not all patients with malaria are being cured. The main objective of the study is to find out which malaria drugs and what drug combinations are still effective in Cambodia, an area of multi-drug resistance where 4-5 artemisinin-based combination therapies have shown inadequate response, below that established by the World Health Organization (WHO). New drug combinations (taking more than one drug for malaria at the same time), as long as well tolerated, can provide cure in patients that harbor parasites not responsive to standard first-line medications. Human genetic testing will be done to identify patients who may have suboptimal response to treatments and to study the differences in human gene expression to explain why some persons are at higher risk of complications during treatment. Markers of drug resistance to commonly used antimalarial drugs will also be evaluated and shared with national malaria program (CNM) to better guide future malaria treatment decisions in Cambodia.
Read the detailed description
Efficacy to drugs that are currently available and new antimalarial candidates that are in development are threatened by multidrug resistant (MDR) malaria parasites, widely prevalent in Cambodia. Without effective interventions, MDR malaria can pose a substantial public health threat in the years to come. Therefore, accurate, timely and relevant data on antimalarial drug resistance is of critical importance. Prompt, effective and well-tolerated treatment remains one of the cornerstones in the malaria case management. Recent malaria outbreak in Thailand and rise of malaria cases observed in Cambodia in 2017 has brought to the forefront the urgency with which new drug candidates and new combination drug treatments must be identified; otherwise, patients may be left with ineffective treatments. Lack of available alternatives has a potential to result in significant setback to the recent gains in malaria control and malaria elimination efforts. Innovative approaches to treatment proposed here, using current ACTs in combination with non-ACT drugs, such as atovaquone-proguanil, need to be investigated to assess drug tolerability and overall efficacy when used under combination treatment. By early investment in the studies of drugs such as pyronaridine-artesunate (ASPY), in combination with other antimalarials, and drug combinations proposed under this protocol, this study will try to provide the latest evidence on the interventions that are most likely to work, even in areas of MDR, such as Cambodia, and along the Cambodia-Thai border. It is hoped that our approach for using combination treatments will not only provide more effective treatments, but it might prolong the lifespan of the remaining antimalarials and delay the spread of MDR malaria to neighboring countries.
- Being tested
- Artesunate and Pyronaridine, Atovaquone Proguanil and Artesunate Pyronaridine, Atovaquone Proguanil and Artesunate Mefloquine
- Keywords
- malaria, plasmodium falciparum, malarone, atovaquone, mefloquine, pyramax, pyronaridine, combination treatment, triple therapy, multidrug resistant malaria
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate and PyronaridineDrug
Standard weight based dosing
Atovaquone Proguanil and Artesunate PyronaridineDrug
Both drugs (AP) and (ASPY) are administered once a day, on days 0, 1, and 2.
Atovaquone Proguanil and Artesunate MefloquineDrug
Sequential treatment with ASMQ (on days 0, 1, and 2) followed by the treatment with AP for 3 more days (total 6 days treatment)
| Study group | Role | What they receive |
|---|---|---|
| ASPY | Experimental | Artesunate-pyronaridine, once daily for three days, following standard weight-based dosing per drug label. All volunteers with P.f monoinfection will receive single dose of primaquine (PQ) (15 mg) for transmission blocking. Receives: Drug: Artesunate and Pyronaridine |
| AP+ASPY | Experimental | Atovaquone-Proguanil (AP) + Artesunate-Pyronaridine (ASPY), once daily for three days, following standard weight-based dosing per drug label for each drug. All volunteers with P.f monoinfection receive single dose of PQ (15 mg) for transmission blocking Receives: Drug: Atovaquone Proguanil and Artesunate Pyronaridine |
| AP+ASMQ | Experimental | Atovaquone-Proguanil (AP) + Artesunate-Mefloquine (ASMQ); ASMQ once daily for three days (D0, D1, D2), following standard weight-based dosing per drug label. Subsequently, volunteers continue their treatment with AP once daily starting on day 3, for three additional days (D3, 4, 5). All volunteers with P.f monoinfection receive single dose of PQ (15 mg) for transmission blocking. Receives: Drug: Atovaquone Proguanil and Artesunate Mefloquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
42-day polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR), following treatment with ASPY and new drug combinations (AP+ACTs).
Measured: 6 weeks
Secondary outcomes (15)
Prevalence of molecular markers of drug resistance
Measured: Day of enrollment and day of malaria recurrence up to 8 weeks
Drug susceptibility testing of parasite isolates against standard antimalarial drugs
Ex vivo drug susceptibility testing
Measured: Day of enrollment and day of malaria recurrence up to 8 weeks
Pharmakokinetics of each study drug - (Cmax)
Peak plasma concentration (Cmax) for study drugs
Measured: multiple time points up to 8 weeks
Pharmakokinetics of each study drug - (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: multiple time points up to 8 weeks
Pharmakokinetics of each study drug - volume of distribution
volume of distribution for study drugs
Measured: multiple time points throughout 6 weeks of follow up
Pharmakokinetics of each study drug - (T1/2)
elimination half-life (T1/2) for study drugs
Measured: multiple time points up to 8 weeks
Kaplan Meier survival analysis of asexual blood stage parasitemia and sexual stage gametocytes
Measured: 6 weeks
Gametocyte carriage rates on days 0, 1, 2, 3, and weeks 1 through 6 for each treatment arm
Measured: Days 0, 1, 2, 3, and weekly, up to week 8
The incidence of hepatotoxicity events for each treatment arm
Alanine aminotransferase (ALT)>5 times the upper limit of normal (ULN) or percent of volunteers meeting the Hy's law definition (ALT or aspartate aminotransferase [AST] >3 x ULN and total bilirubin >2 x ULN) at any post-dose time point within 6 weeks of follow up
Measured: Day 3 and week 6
Rates of treatment-related adverse events
Measured: 6 weeks
Severity of treatment-related adverse events
Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4- life threatening
Measured: 6 weeks
Number of participants who say they are willing to take the same drug combination in the future
Measured: day 2 and week 6
Point efficacy with 95% Confidence Interval against blood stage malaria infection classified according to the WHO malaria treatment outcome classifications (ETF, LTF, LCTF, LPTF)
Measured: 4 weeks, 6 weeks, and 8 weeks
Incidence of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
Comparative incidence of G6PD deficiency in the study population as determined by G6PD rapid-diagnostic tests (RDTs) and quantitative tests, to include sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for each of the point-of-care tests against 10%, 30%, and 60% thresholds of normal G6PD activity
Measured: Enrollment
Number of infected mosquitos following membrane feeding
Measured: Day 0, Day 3, Day 7, and on day of malaria recurrence up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start4 Oct 2018
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum Malaria (Drug Resistant)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label clinical trial to evaluate the tolerability and clinical and parasitological responses after treatment of Pf and/or mixed infections (Pf/Pv) in volunteers with uncomplicated malaria. The assignment of volunteers will be 1:1:1 for ASPY (Pyramax), AP+ASPY (AP+Pyramax), and AP+ASMQ. All study drug administration will be by directly observed therapy (DOT).
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, Thailand
- Sponsor type
- Other government
- Collaborators
- National Center for Parasitology, Entomology, and Malaria Control (CNM), Naval Medical Research Unit-2 (NAMRU-2)
- Responsible party
- Sponsor
- Investigators
- Mariusz Wojnarski, MD, Principal investigator, Armed Forces Research Institute of Medical Sciences (AFRIMS) Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726593
- Sponsor's protocol ID
- WR2530
- Acronym
- APACT
- Status last verified
- Mar 2021
- First submitted
- 16 Oct 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study site will maintain appropriate medical and research records for this trial until completion of the study, in compliance with Section 4.9 of International Conference on Harmonization E6 Good Clinical Practices, and institutional requirements. The investigators and other study personnel assigned from National Center for Parasitology, Entomology and Malaria Control (CNM), Armed Forces Research Institute of Medical Sciences (AFRIMS) and Naval Medical Research Center NMRC-Asia and their respective representatives are authorized access to the study data as part of their duties. The database may be shared with other collaborators, on a mutually agreed basis. Sharing and publication of the data with other parties can be done only after inter-institutional agreements are in place. The research findings may be disseminated to policy makers and other researchers for an informed decision on drug policy for the treatment of malaria.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Therapeutic Efficacy Assessment of Pyronaridine-Artesunate (Pyramax®) and New Drug Combinations With Atovaquone-Proguanil for the Treatment of Uncomplicated P. Falciparum Malaria in Cambodia
- ClinicalTrials.gov ID
- NCT03726593
- Acronym / sponsor ID
- APACT / WR2530
- Keywords
- malaria, plasmodium falciparum, malarone, atovaquone, mefloquine, pyramax, pyronaridine, combination treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, ThailandOther government
- Collaborators
- National Center for Parasitology, Entomology, and Malaria Control (CNM), Naval Medical Research Unit-2 (NAMRU-2)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 31 Oct 2018 (actual)
- 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.
Investigators are conducting this study due to recent reports of many of existing malaria drugs becoming less effective for treatment of malaria. The drugs may not always kill all the parasites, therefore not all patients with malaria are being cured. The main objective of the study is to find out which malaria drugs and what drug combinations are still effective in Cambodia, an area of multi-drug resistance where 4-5 artemisinin-based combination therapies have shown inadequate response, below that established by the World Health Organization (WHO). New drug combinations (taking more than one drug for malaria at the same time), as long as well tolerated, can provide cure in patients that harbor parasites not responsive to standard first-line medications. Human genetic testing will be done to identify patients who may have suboptimal response to treatments and to study the differences in human gene expression to explain why some persons are at higher risk of complications during treatment. Markers of drug resistance to commonly used antimalarial drugs will also be evaluated and shared with national malaria program (CNM) to better guide future malaria treatment decisions in Cambodia.
Detailed description
Efficacy to drugs that are currently available and new antimalarial candidates that are in development are threatened by multidrug resistant (MDR) malaria parasites, widely prevalent in Cambodia. Without effective interventions, MDR malaria can pose a substantial public health threat in the years to come. Therefore, accurate, timely and relevant data on antimalarial drug resistance is of critical importance. Prompt, effective and well-tolerated treatment remains one of the cornerstones in the malaria case management. Recent malaria outbreak in Thailand and rise of malaria cases observed in Cambodia in 2017 has brought to the forefront the urgency with which new drug candidates and new combination drug treatments must be identified; otherwise, patients may be left with ineffective treatments. Lack of available alternatives has a potential to result in significant setback to the recent gains in malaria control and malaria elimination efforts. Innovative approaches to treatment proposed here, using current ACTs in combination with non-ACT drugs, such as atovaquone-proguanil, need to be investigated to assess drug tolerability and overall efficacy when used under combination treatment. By early investment in the studies of drugs such as pyronaridine-artesunate (ASPY), in combination with other antimalarials, and drug combinations proposed under this protocol, this study will try to provide the latest evidence on the interventions that are most likely to work, even in areas of MDR, such as Cambodia, and along the Cambodia-Thai border. It is hoped that our approach for using combination treatments will not only provide more effective treatments, but it might prolong the lifespan of the remaining antimalarials and delay the spread of MDR malaria to neighboring countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, open-label clinical trial to evaluate the tolerability and clinical and parasitological responses after treatment of Pf and/or mixed infections (Pf/Pv) in volunteers with uncomplicated malaria. The assignment of volunteers will be 1:1:1 for ASPY (Pyramax), AP+ASPY (AP+Pyramax), and AP+ASMQ. All study drug administration will be by directly observed therapy (DOT).
| Arm | Type | Receives |
|---|---|---|
| ASPY | Experimental | Drug: Artesunate and PyronaridineArtesunate-pyronaridine, once daily for three days, following standard weight-based dosing per drug label. All volunteers with P.f monoinfection will receive single dose of primaquine (PQ) (15 mg) for transmission blocking. |
| AP+ASPY | Experimental | Drug: Atovaquone Proguanil and Artesunate PyronaridineAtovaquone-Proguanil (AP) + Artesunate-Pyronaridine (ASPY), once daily for three days, following standard weight-based dosing per drug label for each drug. All volunteers with P.f monoinfection receive single dose of PQ (15 mg) for transmission blocking |
| AP+ASMQ | Experimental | Drug: Atovaquone Proguanil and Artesunate MefloquineAtovaquone-Proguanil (AP) + Artesunate-Mefloquine (ASMQ); ASMQ once daily for three days (D0, D1, D2), following standard weight-based dosing per drug label. Subsequently, volunteers continue their treatment with AP once daily starting on day 3, for three additional days (D3, 4, 5). All volunteers with P.f monoinfection receive single dose of PQ (15 mg) for transmission blocking. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Understands Khmer spoken language
- Male or female (18 to 70 years old)
- Microscopic confirmation of asexual stages of Pf or mixed infection with Pf, with baseline asexual parasite densities between 100/µL to 200,000/µL
- Able to take oral medications
- Hemoglobin on day of enrollment ≥9.0 g/dL
Key exclusion criteria (10 listed)
- Known allergic reaction to any of the study drugs or history of severe intolerance to any of the antimalarials used in this study.
- Pregnant or lactating females and females of childbearing potential who do not agree to use an acceptable form of contraception during the study period and for 6 weeks following the last dose of the study drug.
- Symptoms of severe vomiting (inability to tolerate oral fluids or oral medications during the previous 8 hours or vomiting >3 times in the last 24 hrs).
- Diagnosis of severe malaria
- Abnormal liver function tests i.e AST or ALT or total bilirubin > 1.5 upper limit of normal (ULN) with nausea AND right upper quadrant abdominal pain OR jaundice on exam
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 |
|---|---|---|
| Artesunate and PyronaridineStandard weight based dosing | Drug | ASPY |
| Atovaquone Proguanil and Artesunate PyronaridineBoth drugs (AP) and (ASPY) are administered once a day, on days 0, 1, and 2. | Drug | AP+ASPY |
| Atovaquone Proguanil and Artesunate MefloquineSequential treatment with ASMQ (on days 0, 1, and 2) followed by the treatment with AP for 3 more days (total 6 days treatment) | Drug | AP+ASMQ |
Primary outcome
42-day polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR), following treatment with ASPY and new drug combinations (AP+ACTs).
Time frame: 6 weeks
15 secondary outcomes
Prevalence of molecular markers of drug resistance
Time frame: Day of enrollment and day of malaria recurrence up to 8 weeks
Drug susceptibility testing of parasite isolates against standard antimalarial drugs
Time frame: Day of enrollment and day of malaria recurrence up to 8 weeks
Pharmakokinetics of each study drug - (Cmax)
Time frame: multiple time points up to 8 weeks
Pharmakokinetics of each study drug - (AUC)
Time frame: multiple time points up to 8 weeks
Pharmakokinetics of each study drug - volume of distribution
Time frame: multiple time points throughout 6 weeks of follow up
Pharmakokinetics of each study drug - (T1/2)
Time frame: multiple time points up to 8 weeks
Kaplan Meier survival analysis of asexual blood stage parasitemia and sexual stage gametocytes
Time frame: 6 weeks
Gametocyte carriage rates on days 0, 1, 2, 3, and weeks 1 through 6 for each treatment arm
Time frame: Days 0, 1, 2, 3, and weekly, up to week 8
The incidence of hepatotoxicity events for each treatment arm
Time frame: Day 3 and week 6
Rates of treatment-related adverse events
Time frame: 6 weeks
Severity of treatment-related adverse events
Time frame: 6 weeks
Number of participants who say they are willing to take the same drug combination in the future
Time frame: day 2 and week 6
Point efficacy with 95% Confidence Interval against blood stage malaria infection classified according to the WHO malaria treatment outcome classifications (ETF, LTF, LCTF, LPTF)
Time frame: 4 weeks, 6 weeks, and 8 weeks
Incidence of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
Time frame: Enrollment
Number of infected mosquitos following membrane feeding
Time frame: Day 0, Day 3, Day 7, and on day of malaria recurrence up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No. The study site will maintain appropriate medical and research records for this trial until completion of the study, in compliance with Section 4.9 of International Conference on Harmonization E6 Good Clinical Practices, and institutional requirements. The investigators and other study personnel assigned from National Center for Parasitology, Entomology and Malaria Control (CNM), Armed Forces Research Institute of Medical Sciences (AFRIMS) and Naval Medical Research Center NMRC-Asia and their respective representatives are authorized access to the study data as part of their duties. The database may be shared with other collaborators, on a mutually agreed basis. Sharing and publication of the data with other parties can be done only after inter-institutional agreements are in place. The research findings may be disseminated to policy makers and other researchers for an informed decision on drug policy for the treatment of malaria.
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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.
Mariusz Wojnarski, MD principal investigator
Armed Forces Research Institute of Medical Sciences (AFRIMS) Bangkok, Thailand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artesunate and Pyronaridine, Atovaquone Proguanil and Artesunate Pyronaridine and Atovaquone Proguanil and Artesunate Mefloquine in people with Plasmodium Falciparum Malaria (Drug Resistant), run by Armed Forces Research Institute of Medical Sciences, Thailand at 3 sites 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 7 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariusz Wojnarski, MD (+66-84-527-4646, MARIUSZ.WOJNARSKI.MIL@AFRIMS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
42-day polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR), following treatment with ASPY and new drug combinations (AP+ACTs). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.