Malaria, FalciparumPhase 2NCT02389439
Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria
A Phase 2 study testing Pyronaridine-artesunate in people with Malaria, Falciparum, run by University of Oxford at 3 sites in Cambodia.
Trial summary
This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Pyronaridine-artesunate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 3 sitesCambodia
- Study dates
- 1 Mar 2015to 1 Jun 2016
- Phase
- Phase 2
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults and children ≥ 20 kg
- Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever >37.5°c.
- Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
- Capability of taking an oral medication
- Written informed consent given to participate in the trial
- Willingness and ability to adhere to follow-up visit schedule
Who cannot join
- Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age, that is 18 to 45 y/o)
- Female aged 12-18y
- Parasitemia > 150 000/µL).
- Signs or symptoms indicative of severe malaria:
- Impaired consciousness (Blantyre Coma Score <5)
- Severe anaemia (Hct<15%)
Show all 16Show fewer
- Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites
- Respiratory distress
- Severe jaundice
- Known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or to pyronaridine
- History of splenectomy
- Known history or evidence of clinically significant disorders, such as:
- Known active Hepatitis A, e.g. by detection of anti HAV-IgM.
- Known hepatitis B surface antigen (HBsAg) carrier.
- Known hepatitis C antibody (HCV Ab).
- Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range.
Trial locations and contacts
3 sites in 1 country.
Cambodia3 sites
Tasanh Health Centre, Battambang
Battambang
Referral hospital (Pailin)
Pailin
Promoy Health Centre (Pursat)
Pursat
About this study
Official title: Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria
This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.
All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.
Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).
- Conditions
- Malaria, Falciparum
- Being tested
- Pyronaridine-artesunate
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyronaridine-artesunateDrug
Also called Pyramax
| Study group | Role | What they receive |
|---|---|---|
| Pyronaridine-artesunate | Experimental | Pyronaridine-artesunate (Pyramax®, Shin Poong Pharmaceuticals). One tablet contains 60mg artesunate+ 180mg pyronaridine. Dosing will be according to body weight.
It will be taken orally with water, once daily for 3 days. Each dose will be administered under the supervision. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only.
20 - < 24 kg = 1 tab 24 - < 45 kg = 2 tabs 45 - < 65 kg = 3 tabs 65 and above = 4 tabs Receives: Drug: Pyronaridine-artesunate |
What is being measured
The primary outcome is the main question the study is designed to answer.
result of PCR
Measured: 42 day
Secondary outcomes (10)
hepatic biological values
the hepatic biological values will be measured which are AST,ALT,albumin and total bilirubin
Measured: at day 0, 3,7 and day 28
eosinophil count
Measured: at day 0, 3, 7 and day 28
K13 and pfmdr1 of P falciparum resistance
Measured: at day 0, 3, 7 and day 28
numbers of patients with a positive malaria slide 72 hours after treatment initiation
Measured: 72 hours
fever clearance time
the time taken for tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours
Measured: 24 hours
Number of patient with reinfection and recrudescences
Measured: over 42 days
PCR uncorrected ACPR
PCR uncorrected ACPR at 28 days or 42 days for P. falciparum, P. falciparum and mixed infections in Pailin
Measured: at 28 days or 42 days
PCR corrected ACPR
PCR corrected ACPR at 28 days or for P. falciparum, P. vivax and mixed infections and at 42 days for P. falciparum and mixed infections
Measured: at 28 days and 42 days
Gametocyte carriage rates
Measured: at day 0, 3, 7 day 28
gametocyte clearance times
Measured: at day 0, 3, 7 and day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start1 Mar 2015
- Primary completion1 Dec 2015
- Study completion1 Jun 2016
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 Malaria, FalciparumStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- NCHADS - Ministry of Health of Cambodia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389439
- Sponsor's protocol ID
- Cambodia1
- Status last verified
- Apr 2015
- First submitted
- 29 Jan 2015
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leang R, Canavati SE, Khim N, Vestergaard LS, Borghini Fuhrer I, Kim S, Denis MB, Heng P, Tol B, Huy R, Duparc S, Dondorp AM, Menard D, Ringwald P. Efficacy and Safety of Pyronaridine-Artesunate for Treatment of Uncomplicated Plasmodium falciparum Malaria in Western Cambodia. Antimicrob Agents Chemother. 2016 Jun 20;60(7):3884-90. doi: 10.1128/AAC.00039-16. Print 2016 Jul.
PubMed 26926629
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria
- ClinicalTrials.gov ID
- NCT02389439
- Acronym / sponsor ID
- Cambodia1
- Conditions
- Malaria, Falciparum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- NCHADS - Ministry of Health of Cambodia
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 17 Mar 2015 (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.
This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.
All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.
Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyronaridine-artesunate | Experimental | Drug: Pyronaridine-artesunatePyronaridine-artesunate (Pyramax®, Shin Poong Pharmaceuticals). One tablet contains 60mg artesunate+ 180mg pyronaridine. Dosing will be according to body weight. It will be taken orally with water, once daily for 3 days. Each dose will be administered under the supervision. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only. 20 - < 24 kg = 1 tab 24 - < 45 kg = 2 tabs 45 - < 65 kg = 3 tabs 65 and above = 4 tabs |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adults and children ≥ 20 kg
- Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever >37.5°c.
- Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
- Capability of taking an oral medication
- Written informed consent given to participate in the trial
Key exclusion criteria (16 listed)
- Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age, that is 18 to 45 y/o)
- Female aged 12-18y
- Parasitemia > 150 000/µL).
- Signs or symptoms indicative of severe malaria:
- Known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or to pyronaridine
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 |
|---|---|---|
| Pyronaridine-artesunateAlso: Pyramax | Drug | Pyronaridine-artesunate |
Primary outcome
result of PCR
Time frame: 42 day
10 secondary outcomes
hepatic biological values
Time frame: at day 0, 3,7 and day 28
eosinophil count
Time frame: at day 0, 3, 7 and day 28
K13 and pfmdr1 of P falciparum resistance
Time frame: at day 0, 3, 7 and day 28
numbers of patients with a positive malaria slide 72 hours after treatment initiation
Time frame: 72 hours
fever clearance time
Time frame: 24 hours
Number of patient with reinfection and recrudescences
Time frame: over 42 days
PCR uncorrected ACPR
Time frame: at 28 days or 42 days
PCR corrected ACPR
Time frame: at 28 days and 42 days
Gametocyte carriage rates
Time frame: at day 0, 3, 7 day 28
gametocyte clearance times
Time frame: at day 0, 3, 7 and day28
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 20 Sep 2018.
- Derived from this study: PubMed 26926629Leang R, Canavati SE, Khim N, Vestergaard LS, Borghini Fuhrer I, Kim S, Denis MB, Heng P, Tol B, Huy R, Duparc S, Dondorp AM, Menard D, Ringwald P. Efficacy and Safety of Pyronaridine-Artesunate for Treatment of Uncomplicated Plasmodium falciparum Malaria in Western Cambodia. Antimicrob Agents Chemother. 2016 Jun 20;60(7):3884-90. doi: 10.1128/AAC.00039-16. Print 2016 Jul.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyronaridine-artesunate in people with Malaria, Falciparum, run by University of Oxford 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 6 inclusion and 16 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 20 Sep 2018. 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 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?
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?
result of PCR (time frame: 42 day). 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 NCT02389439, 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 20 Sep 2018.