Malaria, FalciparumPhase 4ArtesunateNCT02084602
Assessment of Artesunate/Mefloquine in the Peruvian Amazon
A Phase 4 study testing Artesunate and Mefloquine in people with Malaria, Falciparum, run by Instituto Nacional de Salud. Peru at 1 site in Peru.
Trial summary
There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Artesunate and Mefloquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePeru
- Study dates
- 18 Jun 2014to 13 Apr 2016
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 5 and 65 years old inclusive
- Monoinfection of P. falciparum confirmed by microscopy
- Documented fever (axillary temperature > 37.5°C) and/or history of fever during the previous 48 hours in the absence of other obvious causes of fever (such as pneumonia, otitis media, etc)
- Infection with P. falciparum of 1000 and 100,000 asexual parasites per microliter (μl) to be determined by microscopic examination of a thick or thin smear, and positive confirmation by polymerase chain reaction (PCR); * Presence of sexual form of P. vivax is acceptable; ** PCR confirmation is not an enrollment requirement
- Informed consent must be obtained from the participant or both parents/guardian (in the case of children), and assent from the child (from 8 to 17 years old)
- Willingness of the participant to return to the health facility for regular check-ups during the follow-up period of 42 days
- Willingness of the participant to transfer to the Hospital de Apoyo Iquitos to start treatment
Who cannot join
- Severe malaria signs (as defined by the World Health Organization):
- Cerebral malaria (irreversible coma)
- Severe anemia (hematocrit < 15%, or clinic signs)
- Clinic signs of kidney failure (e.g., serum creatinine > 3 mg/dL)
- Pulmonary edema
- Hypoglycemia (glucose in the blood <40mg/dL or clinic signs)
Show all 19Show fewer
- Shock (PA systolic < 70 mm Hg in adults; < 50 in children)
- Spontaneous bleeding/Disseminated intravascular coagulation (CID)
- Recurrent generalized convulsions
- Acidemia/acidosis (clinic signs)
- Macroscopic hemoglobinuria
- Jaundice Laboratory tests for measuring some of these conditions may not be available at all study sites. If they are not, we will use clinical criteria of severe malaria at the discretion of the study physician
- Background of other chronic or severe diseases (e.g., heart, kidney, liver diseases, HIV/AIDS, severe malnutrition), determined clinically by medical history and physical examination
- Background of hypersensitivity to any of the drugs tested or used as an alternative treatment: AS, MQ, quinine or tetracycline/clindamycin
- Gestation (based on a serum pregnancy test or medical history) or desire to become pregnant during the study period, or not using any family planning method while being sexually active (confirmed by urine pregnancy test)
- Breastfeeding a child under 6 months old
- Have received antimalarial drugs in the previous 7 days
- Inability to eat or drink, vomiting (more than twice in the last 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand
- Splenectomy background
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of in Vivo and in Vitro Efficacy of Combined Artesunate/Mefloquine Therapy for Treatment of Uncomplicated Plasmodium Falciparum Infection in the Peruvian Amazon
There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border.
The purpose of this research study, is to assess the in vitro and in vivo efficacy of combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia and other important outcomes.
Read the detailed description
Combination therapy with artemisinin derivatives is the treatment of choice for malaria by P. falciparum since 2006, but there is growing evidence of the emergence of P. falciparum resistance to artesunate in Southeast Asia. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region.
This research study, will be conducted in collaboration with the National Institute of Health of Peru.
Objectives:
Main Objective: To determine the rate of clearance of parasitemia in the first 72 hours after administration of artesunate.
Secondary/exploratory objectives:
- to determine the efficacy of the artesunate (AS)/mefloquine (MQ) therapy in participants with uncomplicated falciparum malaria in the Peruvian Amazon (sub-study);
- to correlate the clinical results from the in vivo study with results of in vitro sensitivity and molecular genotyping;
- to identify common specific genetic determinants to the resistance of artemisinins in parasite populations;
- to determine the levels of gametocytes in participants with uncomplicated falciparum malaria treated with AS/MQ;
- to determine the contribution of host immunity in clinical and parasitological response;
- to create a catalog of parasite samples closely correlated with clinical response data to perform a longitudinal follow-up of resistance trends;
- to determine pharmacokinetic parameters associated with failure of therapy.
Methodology:
The study will be conducted in seven health facilities and one hospital in the Department of Loreto in the Peruvian Amazon, where 59 volunteers will be enrolled between 5 and 65 years of age with confirmed diagnosis of monoinfection by P. falciparum. In addition to the main study, we will conduct a sub-study to determine the efficacy of AS/MQ (regime currently used in Peru) After signing the informed consent/assent, blood samples will be taken to determine parasite density, baseline biochemical tests, genotyping studies, analysis of molecular markers and in vitro sensitivity, antibodies against malaria and cytokines. Artesunate will be administered according to national guidelines in the first three days, 4 mg/kg/day. However, mefloquine administration will be delayed for up to 72 hours to measure the rate of clearance of parasitemia with artesunate alone in the first three days. Serial blood samples for thick/thin smears will be taken every 4 hours during the first 12 hours and then every 6 hours until complete the first 72 hours, after the AS administration, during which time the study participants will remain in a hospital ward. Monitoring will be undertaken until day 42 with analysis of thick/thin smears according to WHO guidelines. In case of parasitemia recurrence, additional blood samples will be collected for genotyping tests, in vitro sensitivity, and analysis of molecular markers of drug resistance and immunology assays. The sub-study will be useful to assess the efficacy of the regimen currently in use by the Ministry of Health of Peru, in this arm the patients will be given AS 4 mg/kg/day in Days 0, 1 and 2 and MQ 12.5mg/kg/day in Days 1 and 2. In this arm, the follow up will be done using thick smears on Days 1, 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples will be collected on Days 0, 42 and the day of recurrence.
This study will allow the Ministry of Health to know the state of resistance/tolerance to artesunate in Peru and take the necessary control measures to ensure that artesunate can be used successfully for treatment of falciparum malaria. Importantly, the results of this study will be compared to parallelly-designed studies in Kenya (US Army Medical Research Unit Kenya-USAMRU K) and Thailand (Army Forces Medical Research Institute of Medical Sciences-AFRIMS).
Relevance: Malaria is one of the main public health problems in Peru, early and efficacious treatment in the principal control strategy the appearance of strains that are resistant to the regular treatment used in Peru jeopardize the strategies for malaria control in South America. This study will allow us to know the current resistance status and to prepare corresponding measures.
Budget: This study will be done as a joined effort between NAMRU-6 and the INS, this will cost 201,934.93 Nuevos Soles afforded by Instituto Nacional de Salud and a total cost of 527,934.93 Nuevos Soles for both participating institutions
- Conditions
- Malaria, Falciparum
- Being tested
- Artesunate, Mefloquine
- Keywords
- artesunate, mefloquine, falciparum, peruvian amazon
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesunateDrug
Also called Distribuited by AC Farma
Orally administration of artesunate 4mg/Kg by three days
MefloquineDrug
Also called Distribuited by AC Farma
Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day
| Study group | Role | What they receive |
|---|---|---|
| Artesunate/mefloquine | Experimental | Orally administration of artesunate 4mg/Kg by three days Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day Receives: Drug: Artesunate; Drug: Mefloquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite clearance time
Parasite clearance time assessed by microscopy and quantitative PCR
Measured: up to 72 hours after administration of artesunate
Secondary outcomes (4)
Parasite reduction rates and ratios
Parasite reduction rates and ratios assessed by microscopy and quantitative PCR
Measured: 24, 48 hours after the first administration of artesunate
Time for parasite count to fall
Time for parasite count to fall to 50%, 90% and 99% of initial parasite density
Measured: at least 24 hours
Fever clearance time
Time taken for temperature to fall below 37˚C and remain there for at least 24 hours
Measured: at least 24 hours
Gametocyte carriage rates
Gametocyte carriage rates assessed in person weeks up to 14 days
Measured: up to 14 days since the first administration of artesunate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study start18 Jun 2014
- Primary completion6 Nov 2015
- Study completion13 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud. Peru
- Sponsor type
- Other government
- Collaborators
- U.S. Naval Medical Research Unit No.6 (NAMRU-6)
- Responsible party
- Sponsor
- Investigators
- Salomon Durand, Master, Principal investigator, NAMRU 6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084602
- Sponsor's protocol ID
- U.2012.0008
- Acronym
- Artesunate
- Status last verified
- Apr 2021
- First submitted
- 7 Mar 2014
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Durand S, Sihuincha M, Lachira A, Chaves J, Cabezas C. [A need to monitor P. falciparum resistance to artesunate in Peru]. Rev Peru Med Exp Salud Publica. 2012 Oct-Dec;29(4):579-80. doi: 10.1590/s1726-46342012000400028. No abstract available. Spanish.
PubMed 23338651de Oliveira AM, Chavez J, de Leon GP, Durand S, Arrospide N, Roberts J, Cabezas C, Marquino W. Efficacy and effectiveness of mefloquine and artesunate combination therapy for uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon. Am J Trop Med Hyg. 2011 Sep;85(3):573-8. doi: 10.4269/ajtmh.2011.11-0250.
PubMed 21896825Gutman J, Green M, Durand S, Rojas OV, Ganguly B, Quezada WM, Utz GC, Slutsker L, Ruebush TK 2nd, Bacon DJ. Mefloquine pharmacokinetics and mefloquine-artesunate effectiveness in Peruvian patients with uncomplicated Plasmodium falciparum malaria. Malar J. 2009 Apr 9;8:58. doi: 10.1186/1475-2875-8-58.
PubMed 19358697Alker AP, Lim P, Sem R, Shah NK, Yi P, Bouth DM, Tsuyuoka R, Maguire JD, Fandeur T, Ariey F, Wongsrichanalai C, Meshnick SR. Pfmdr1 and in vivo resistance to artesunate-mefloquine in falciparum malaria on the Cambodian-Thai border. Am J Trop Med Hyg. 2007 Apr;76(4):641-7.
PubMed 17426163Wongsrichanalai C, Meshnick SR. Declining artesunate-mefloquine efficacy against falciparum malaria on the Cambodia-Thailand border. Emerg Infect Dis. 2008 May;14(5):716-9. doi: 10.3201/eid1405.071601.
PubMed 18439351
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of in Vivo and in Vitro Efficacy of Combined Artesunate/Mefloquine Therapy for Treatment of Uncomplicated Plasmodium Falciparum Infection in the Peruvian Amazon
- ClinicalTrials.gov ID
- NCT02084602
- Acronym / sponsor ID
- Artesunate / U.2012.0008
- Conditions
- Malaria, Falciparum
- Keywords
- artesunate, mefloquine, falciparum, peruvian amazon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud. PeruOther government
- Collaborators
- U.S. Naval Medical Research Unit No.6 (NAMRU-6)
- Study start
- 18 Jun 2014 (actual)
- Primary completion
- 6 Nov 2015 (actual)
- Study completion
- 13 Apr 2016 (actual)
- First posted
- 12 Mar 2014 (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.
There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border.
The purpose of this research study, is to assess the in vitro and in vivo efficacy of combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia and other important outcomes.
Detailed description
Combination therapy with artemisinin derivatives is the treatment of choice for malaria by P. falciparum since 2006, but there is growing evidence of the emergence of P. falciparum resistance to artesunate in Southeast Asia. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region.
This research study, will be conducted in collaboration with the National Institute of Health of Peru.
Objectives:
Main Objective: To determine the rate of clearance of parasitemia in the first 72 hours after administration of artesunate.
Secondary/exploratory objectives:
- to determine the efficacy of the artesunate (AS)/mefloquine (MQ) therapy in participants with uncomplicated falciparum malaria in the Peruvian Amazon (sub-study);
- to correlate the clinical results from the in vivo study with results of in vitro sensitivity and molecular genotyping;
- to identify common specific genetic determinants to the resistance of artemisinins in parasite populations;
- to determine the levels of gametocytes in participants with uncomplicated falciparum malaria treated with AS/MQ;
- to determine the contribution of host immunity in clinical and parasitological response;
- to create a catalog of parasite samples closely correlated with clinical response data to perform a longitudinal follow-up of resistance trends;
- to determine pharmacokinetic parameters associated with failure of therapy.
Methodology:
The study will be conducted in seven health facilities and one hospital in the Department of Loreto in the Peruvian Amazon, where 59 volunteers will be enrolled between 5 and 65 years of age with confirmed diagnosis of monoinfection by P. falciparum. In addition to the main study, we will conduct a sub-study to determine the efficacy of AS/MQ (regime currently used in Peru) After signing the informed consent/assent, blood samples will be taken to determine parasite density, baseline biochemical tests, genotyping studies, analysis of molecular markers and in vitro sensitivity, antibodies against malaria and cytokines. Artesunate will be administered according to national guidelines in the first three days, 4 mg/kg/day. However, mefloquine administration will be delayed for up to 72 hours to measure the rate of clearance of parasitemia with artesunate alone in the first three days. Serial blood samples for thick/thin smears will be taken every 4 hours during the first 12 hours and then every 6 hours until complete the first 72 hours, after the AS administration, during which time the study participants will remain in a hospital ward. Monitoring will be undertaken until day 42 with analysis of thick/thin smears according to WHO guidelines. In case of parasitemia recurrence, additional blood samples will be collected for genotyping tests, in vitro sensitivity, and analysis of molecular markers of drug resistance and immunology assays. The sub-study will be useful to assess the efficacy of the regimen currently in use by the Ministry of Health of Peru, in this arm the patients will be given AS 4 mg/kg/day in Days 0, 1 and 2 and MQ 12.5mg/kg/day in Days 1 and 2. In this arm, the follow up will be done using thick smears on Days 1, 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples will be collected on Days 0, 42 and the day of recurrence.
This study will allow the Ministry of Health to know the state of resistance/tolerance to artesunate in Peru and take the necessary control measures to ensure that artesunate can be used successfully for treatment of falciparum malaria. Importantly, the results of this study will be compared to parallelly-designed studies in Kenya (US Army Medical Research Unit Kenya-USAMRU K) and Thailand (Army Forces Medical Research Institute of Medical Sciences-AFRIMS).
Relevance: Malaria is one of the main public health problems in Peru, early and efficacious treatment in the principal control strategy the appearance of strains that are resistant to the regular treatment used in Peru jeopardize the strategies for malaria control in South America. This study will allow us to know the current resistance status and to prepare corresponding measures.
Budget: This study will be done as a joined effort between NAMRU-6 and the INS, this will cost 201,934.93 Nuevos Soles afforded by Instituto Nacional de Salud and a total cost of 527,934.93 Nuevos Soles for both participating institutions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artesunate/mefloquine | Experimental | Drug: Artesunate, Drug: MefloquineOrally administration of artesunate 4mg/Kg by three days Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 5 and 65 years old inclusive
- Monoinfection of P. falciparum confirmed by microscopy
- Documented fever (axillary temperature > 37.5°C) and/or history of fever during the previous 48 hours in the absence of other obvious causes of fever (such as pneumonia, otitis media, etc)
- Infection with P. falciparum of 1000 and 100,000 asexual parasites per microliter (μl) to be determined by microscopic examination of a thick or thin smear, and positive confirmation by polymerase chain reaction (PCR); * Presence of sexual form of P. vivax is acceptable; ** PCR confirmation is not an enrollment requirement
- Informed consent must be obtained from the participant or both parents/guardian (in the case of children), and assent from the child (from 8 to 17 years old)
Key exclusion criteria (19 listed)
- Severe malaria signs (as defined by the World Health Organization):
- Background of other chronic or severe diseases (e.g., heart, kidney, liver diseases, HIV/AIDS, severe malnutrition), determined clinically by medical history and physical examination
- Background of hypersensitivity to any of the drugs tested or used as an alternative treatment: AS, MQ, quinine or tetracycline/clindamycin
- Gestation (based on a serum pregnancy test or medical history) or desire to become pregnant during the study period, or not using any family planning method while being sexually active (confirmed by urine pregnancy test)
- Breastfeeding a child under 6 months old
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 |
|---|---|---|
| ArtesunateAlso: Distribuited by AC FarmaOrally administration of artesunate 4mg/Kg by three days | Drug | Artesunate/mefloquine |
| MefloquineAlso: Distribuited by AC FarmaOrally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day | Drug | Artesunate/mefloquine |
Primary outcome
Parasite clearance time
Time frame: up to 72 hours after administration of artesunate
Parasite clearance time assessed by microscopy and quantitative PCR
4 secondary outcomes
Parasite reduction rates and ratios
Time frame: 24, 48 hours after the first administration of artesunate
Time for parasite count to fall
Time frame: at least 24 hours
Fever clearance time
Time frame: at least 24 hours
Gametocyte carriage rates
Time frame: up to 14 days since the first administration of artesunate
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 29 Apr 2021.
- Background: PubMed 23338651Durand S, Sihuincha M, Lachira A, Chaves J, Cabezas C. [A need to monitor P. falciparum resistance to artesunate in Peru]. Rev Peru Med Exp Salud Publica. 2012 Oct-Dec;29(4):579-80. doi: 10.1590/s1726-46342012000400028. No abstract available. Spanish.
- Background: PubMed 21896825de Oliveira AM, Chavez J, de Leon GP, Durand S, Arrospide N, Roberts J, Cabezas C, Marquino W. Efficacy and effectiveness of mefloquine and artesunate combination therapy for uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon. Am J Trop Med Hyg. 2011 Sep;85(3):573-8. doi: 10.4269/ajtmh.2011.11-0250.
- Background: PubMed 19358697Gutman J, Green M, Durand S, Rojas OV, Ganguly B, Quezada WM, Utz GC, Slutsker L, Ruebush TK 2nd, Bacon DJ. Mefloquine pharmacokinetics and mefloquine-artesunate effectiveness in Peruvian patients with uncomplicated Plasmodium falciparum malaria. Malar J. 2009 Apr 9;8:58. doi: 10.1186/1475-2875-8-58.
- Background: PubMed 17426163Alker AP, Lim P, Sem R, Shah NK, Yi P, Bouth DM, Tsuyuoka R, Maguire JD, Fandeur T, Ariey F, Wongsrichanalai C, Meshnick SR. Pfmdr1 and in vivo resistance to artesunate-mefloquine in falciparum malaria on the Cambodian-Thai border. Am J Trop Med Hyg. 2007 Apr;76(4):641-7.
- Background: PubMed 18439351Wongsrichanalai C, Meshnick SR. Declining artesunate-mefloquine efficacy against falciparum malaria on the Cambodia-Thailand border. Emerg Infect Dis. 2008 May;14(5):716-9. doi: 10.3201/eid1405.071601.
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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.
Salomon Durand, Master principal investigator
NAMRU 6
1 site 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 Mefloquine in people with Malaria, Falciparum, run by Instituto Nacional de Salud. Peru at 1 site in Peru.
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 19 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 29 Apr 2021. 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 Peru. 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?
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?
Parasite clearance time (time frame: up to 72 hours after administration of artesunate). 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 NCT02084602, which also lists 5 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 29 Apr 2021.