MalariaPhase 3NCT01378286
Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria
A Phase 3 study testing ARTESUNATE + AMODIAQUINE and Chloroquine in people with Malaria, run by Sanofi at 1 site in Brazil.
Trial summary
Primary Objective: To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine Secondary Objectives: To assess the non inferiority on the same way as the main criteria: at Day 28 before corrected cure rate at Day 14 and… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria
- What is being tested?
- ARTESUNATE + AMODIAQUINE and Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 3
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults and children over 6 months old and bodyweight > 5 kg
- Able to be treated by oral route
- Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days
- Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood
- Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.
Who cannot join
- Known project of leaving the investigator site area during the follow-up period (42 days)
- Hypersensitivity to one of the investigational medicinal products or to any of the excipients
- Intake of an antimalarial treatment in the previous 30 days
- History of hepatic and (or) haematological impairment during treatment with amodiaquine
- Blurred vision suggesting a retinopathy
- Presence of at least one danger sign of malaria
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- Pregnant or breast-feeding women
- Women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study
- Known severe concomitant or underlying disease
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria
Primary Objective:
- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine
Read more
Secondary Objectives:
- To assess the non inferiority on the same way as the main criteria:
- at Day 28 before corrected cure rate
- at Day 14 and Day 42 before and after corrected cure rate
- To compare the two groups of treatment in terms of:
- Efficacy:
- Proportion of aparasitaemic patients at 24, 48 an 72 hours
- Proportion of afebrile patients at 24, 48 and 72 hours
- Percentage of gametocyte carriers during follow-up
- Evolution of the mean of gametocytes during the 42 days of follow-up
- Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28
- Clinical and biological tolerability:
- Proportion of any adverse event
- Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins)
- ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above
Read the detailed description
Each patient will be followed for a period of 42 days
- Conditions
- Malaria
- Being tested
- ARTESUNATE + AMODIAQUINE, Chloroquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTESUNATE + AMODIAQUINEDrug
Pharmaceutical form:
Route of administration:
ChloroquineDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| artesunate/amodiaquine | Experimental | artesunate (AS) / amodiaquine (AQ) as fixed dose combination
1 tablet of AS 25mg/ AQ 67,5mg or AS 50mg/AQ 135mg or AS 100mg/ AQ 270mg or 2 tablets of AS 100mg/ AQ 270mg dose according to bodyweight Once daily 3 days of treatment Receives: Drug: ARTESUNATE + AMODIAQUINE |
| chloroquine | Active comparator | 150mg tablets 25mg/kg in 3 days (10mg/kg on day 1 and 7,5 mg/kg on days 2 and 3) dose according to bodyweight Once daily 3 days of treatment Receives: Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
Measured: 28 days
Secondary outcomes (8)
Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28
Measured: up to a maximum of 42 days
Number of patients without parasite
Measured: up to a maximum of 42 days
Number of patients without fever
Measured: up to a maximum of 42 days
Number of patients with gametocytes
Measured: up to a maximum of 42 days
Change from baseline in Haemoglobin levels
Measured: Day 7, Day 28
Incidence and severity of adverse events collected
Measured: up to a maximum of 42 days
ECG (QTc) changes in patients group aged >= 10 years from baseline
Measured: Day 3, Day 28
Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline
Measured: up to a maximum of 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378286
- Sponsor's protocol ID
- ARAMF_C_05370
- Other IDs
- U1111-1120-0233
- Status last verified
- Jul 2013
- First submitted
- 20 Jun 2011
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siqueira AM, Alencar AC, Melo GC, Magalhaes BL, Machado K, Alencar Filho AC, Kuehn A, Marques MM, Manso MC, Felger I, Vieira JL, Lameyre V, Daniel-Ribeiro CT, Lacerda MV. Fixed-Dose Artesunate-Amodiaquine Combination vs Chloroquine for Treatment of Uncomplicated Blood Stage P. vivax Infection in the Brazilian Amazon: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2017 Jan 15;64(2):166-174. doi: 10.1093/cid/ciw706. Epub 2016 Oct 20.
PubMed 27988484
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria
- ClinicalTrials.gov ID
- NCT01378286
- Acronym / sponsor ID
- ARAMF_C_05370
- Conditions
- Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jun 2011 (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.
Primary Objective:
- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine
Secondary Objectives:
- To assess the non inferiority on the same way as the main criteria:
- at Day 28 before corrected cure rate
- at Day 14 and Day 42 before and after corrected cure rate
- To compare the two groups of treatment in terms of:
- Efficacy:
- Proportion of aparasitaemic patients at 24, 48 an 72 hours
- Proportion of afebrile patients at 24, 48 and 72 hours
- Percentage of gametocyte carriers during follow-up
- Evolution of the mean of gametocytes during the 42 days of follow-up
- Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28
- Clinical and biological tolerability:
- Proportion of any adverse event
- Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins)
- ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above
Detailed description
Each patient will be followed for a period of 42 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artesunate/amodiaquine | Experimental | Drug: ARTESUNATE + AMODIAQUINEartesunate (AS) / amodiaquine (AQ) as fixed dose combination 1 tablet of AS 25mg/ AQ 67,5mg or AS 50mg/AQ 135mg or AS 100mg/ AQ 270mg or 2 tablets of AS 100mg/ AQ 270mg dose according to bodyweight Once daily 3 days of treatment |
| chloroquine | Active comparator | Drug: Chloroquine150mg tablets 25mg/kg in 3 days (10mg/kg on day 1 and 7,5 mg/kg on days 2 and 3) dose according to bodyweight Once daily 3 days of treatment |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adults and children over 6 months old and bodyweight > 5 kg
- Able to be treated by oral route
- Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days
- Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood
- Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.
Key exclusion criteria (10 listed)
- Known project of leaving the investigator site area during the follow-up period (42 days)
- Hypersensitivity to one of the investigational medicinal products or to any of the excipients
- Intake of an antimalarial treatment in the previous 30 days
- History of hepatic and (or) haematological impairment during treatment with amodiaquine
- Blurred vision suggesting a retinopathy
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 + AMODIAQUINEPharmaceutical form: Route of administration: | Drug | artesunate/amodiaquine |
| ChloroquinePharmaceutical form:tablet Route of administration: oral | Drug | chloroquine |
Primary outcome
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
Time frame: 28 days
8 secondary outcomes
Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28
Time frame: up to a maximum of 42 days
Number of patients without parasite
Time frame: up to a maximum of 42 days
Number of patients without fever
Time frame: up to a maximum of 42 days
Number of patients with gametocytes
Time frame: up to a maximum of 42 days
Change from baseline in Haemoglobin levels
Time frame: Day 7, Day 28
Incidence and severity of adverse events collected
Time frame: up to a maximum of 42 days
ECG (QTc) changes in patients group aged >= 10 years from baseline
Time frame: Day 3, Day 28
Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline
Time frame: up to a maximum of 42 days
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 18 Jul 2013.
- Derived from this study: PubMed 27988484Siqueira AM, Alencar AC, Melo GC, Magalhaes BL, Machado K, Alencar Filho AC, Kuehn A, Marques MM, Manso MC, Felger I, Vieira JL, Lameyre V, Daniel-Ribeiro CT, Lacerda MV. Fixed-Dose Artesunate-Amodiaquine Combination vs Chloroquine for Treatment of Uncomplicated Blood Stage P. vivax Infection in the Brazilian Amazon: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2017 Jan 15;64(2):166-174. doi: 10.1093/cid/ciw706. Epub 2016 Oct 20.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARTESUNATE + AMODIAQUINE and Chloroquine in people with Malaria, run by Sanofi at 1 site in Brazil.
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 5 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: finished, as of the sponsor's last update on 18 Jul 2013. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction (time frame: 28 days). 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 NCT01378286, 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 18 Jul 2013.