Plasmodium Falciparum Malaria (Drug Resistant)Phase 2ArtesynibNCT03697668
Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites
A Phase 2 study testing Imatinib and Dihydroartemisinin-piperaquine in people with Plasmodium Falciparum Malaria (Drug Resistant), run by Nurex S.r.l. at 1 site in Vietnam.
Trial summary
The purpose of this study is to provide a new drug combination for a better treatment of P. falciparum for a faster parasite clearance and to counteract artemisinin resistance. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Plasmodium Falciparum Malaria (Drug Resistant)
- What is being tested?
- Imatinib and Dihydroartemisinin-piperaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 17 Sep 2017to 31 Dec 2019
- 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 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with mild to moderate P. falciparum malaria
- Adult male, age 18-55 years
- Good health conditions other than malaria
- The patient did not take anti-malarial drugs in the past 4 weeks
Who cannot join
- unable to provide Informed Consent or Patient History Form
- symptoms and signs of severe or complicated malaria including: continuous high fever over 39 °C, confusion, convulsions
- parasitemia<150.000 parasites /microliter
- other neurological or psychiatric symptoms or disorders
- abnormal bleeding
- resting hearth rate lower than 60 and higher than 100 bpm
Show all 27Show fewer
- abnormal ECG, history of cardiac diseases
- male adults with corrected QT intervals > 450ms
- signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system
- hemoglobin < 9.0 gm/100ml
- symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.
- patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption
- concomitant infection by plasmodium species other than P. falciparum
- inability to meet daily with local doctor during period of clinical trial
- concomitant medicines like:
- medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin, simvastatin);
- medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);
- medicined used to treat HIV (antiretroviral medicines): protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine);
- medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
- medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;
- medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital), carbamazepine or phenytoin;
- medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);
- sex hormones, including those contained in hormonal contraceptives (such as gestodene, progesterone, estradiol), testosterone; - glucocorticoids (hydrocortisone, dexamethasone); - omeprazole (used to treat diseases related to gastric acid production);
- paracetamol (used to treat pain and fever);
- theophylline (used to improve bronchial air flow);
- nefazodone (used to treat depression);
- aprepitant (used to treat nausea);
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
A Tuc
Hương Hóa, Quang Tri, 520000
Tuan A Tran, MD, +84982290426, tuanhuonghoa@gmail.com
About this study
Official title: Triple Antimalarial Combination (Imatinib-DHA-PPQ) to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites
The purpose of this study is to provide a new drug combination for a better treatment of P. falciparum for a faster parasite clearance and to counteract artemisinin resistance.
Read the detailed description
According to WHO, resistance to artemisinin derivatives (ART) is emerging in many areas of the Greater Mekong Region as a delayed parasite clearance following a standard treatment by artemisinin combined therapy (ACT). Artemisinin resistance is often accompanied by the resistance to the partner drugs such as piperaquine (PPQ), mefloquine (MEF), amodiaquine (AQ) and lumefantrine (LF).
The slow and incomplete clearance of parasites following ACT treatment is considered to permit the selection of resistant parasites.
The availability of new, more efficient treatments accelerating the clearance of parasites is therefore needed to counteract the selection of ART resistant strains.
Imatinib (IMA) has been demonstrated to increase the efficacy of ART in a synergic fashion. This positive effect is further potentiated by low concentrations of PPQ.
IMA is active both on the intra-erythrocyte asexual forms and on gametocytes. It is therefore expected that the combination DHA-PPQ-IMA should lead to faster and radical clearance of the parasites, therefore reducing the frequency of healthy carriers and transmission.
- Being tested
- Imatinib, Dihydroartemisinin-piperaquine
- Keywords
- Imatinib Mesylate, piperaquine phosphate, dihydroartemisinin
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Gleevec, Glivec
triple combination for the treatment of malaria
Dihydroartemisinin-piperaquineDrug
Also called Artekin, Eurartesim, Diphos, Timequin
standard malaria treatment
| Study group | Role | What they receive |
|---|---|---|
| imatinib-Dihydroartemisinin-piperaquine | Experimental | triple combination Receives: Drug: Imatinib |
| Dihydroartemisinin-piperaquine | Active comparator | standard of care Receives: Drug: Dihydroartemisinin-piperaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events
Occurrence of Adverse Events over 42 days observation period
Measured: From baseline to day 42
Occurrence of Severe Adverse Events
Occurrence of Severe Adverse Events over 42 days observation period
Measured: From baseline to day 42
Occurrence of Abnormal Physical Symptoms
Occurrence of Abnormal Physical Symptoms (Clinical Abnormalities) over 42 days observation period
Measured: From baseline to day 42
Occurrence of Abnormal Laboratory Values
Occurrence of Abnormal Laboratory Values over 42 days observation period
Measured: From baseline to day 42
Secondary outcomes (4)
Frequency of residual parasitemia: % of patients with >1000 parasites/ ul at day 3 and 28
Parasitemia is determined by assessing the parasite count in blood, using thin film, thick film and qPCR analysis.
Measured: day 3 and day 28
Frequency of fever and malaria symptoms
Percentage of patients with fever or malaria symptoms observed at Phisical Visit at day 3 and 28.
Measured: day 3 and day 28
Mean parasitemia in the control and investigational arms
Mean parasitemia by assessing the parasite count in blood, using thin film, thick film and qPCR analysis, expressed as parasites / ul at day 2, 3 and 5 measured in the control and investigational arms
Measured: day 2 and day 5
Parasite half-life measured at 12 and 24 hours
Mean parasite clearance half-life calculated using parasitemia measured at baseline, 12 and 24 hours post-treatment
Measured: from baseline to 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start17 Sep 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- interventional
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurex S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Università degli Studi di Sassari, Purdue University, Vinmec Healthcare System
- Responsible party
- Sponsor
- Investigators
- Huynh D Chien, MD, PhD, Principal investigator, UNIVERSITY OF HUE, VIETNAM AND VINMEC DANANG INTERNATIONAL HOSPITAL, Hai Chau, Danang.Francesco M Turrini, MD, PhD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697668
- Sponsor's protocol ID
- NUREX S.r.l
- Acronym
- Artesynib
- Status last verified
- Oct 2018
- First submitted
- 2 Jul 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Antimalarial Combination (Imatinib-DHA-PPQ) to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites
- ClinicalTrials.gov ID
- NCT03697668
- Acronym / sponsor ID
- Artesynib / NUREX S.r.l
- Keywords
- Imatinib Mesylate, piperaquine phosphate, dihydroartemisinin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nurex S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Università degli Studi di Sassari, Purdue University, Vinmec Healthcare System
- Study start
- 17 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 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.
The purpose of this study is to provide a new drug combination for a better treatment of P. falciparum for a faster parasite clearance and to counteract artemisinin resistance.
Detailed description
According to WHO, resistance to artemisinin derivatives (ART) is emerging in many areas of the Greater Mekong Region as a delayed parasite clearance following a standard treatment by artemisinin combined therapy (ACT). Artemisinin resistance is often accompanied by the resistance to the partner drugs such as piperaquine (PPQ), mefloquine (MEF), amodiaquine (AQ) and lumefantrine (LF).
The slow and incomplete clearance of parasites following ACT treatment is considered to permit the selection of resistant parasites.
The availability of new, more efficient treatments accelerating the clearance of parasites is therefore needed to counteract the selection of ART resistant strains.
Imatinib (IMA) has been demonstrated to increase the efficacy of ART in a synergic fashion. This positive effect is further potentiated by low concentrations of PPQ.
IMA is active both on the intra-erythrocyte asexual forms and on gametocytes. It is therefore expected that the combination DHA-PPQ-IMA should lead to faster and radical clearance of the parasites, therefore reducing the frequency of healthy carriers and transmission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- interventional
| Arm | Type | Receives |
|---|---|---|
| imatinib-Dihydroartemisinin-piperaquine | Experimental | Drug: Imatinibtriple combination |
| Dihydroartemisinin-piperaquine | Active comparator | Drug: Dihydroartemisinin-piperaquinestandard of care |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with mild to moderate P. falciparum malaria
- Adult male, age 18-55 years
- Good health conditions other than malaria
- The patient did not take anti-malarial drugs in the past 4 weeks
Key exclusion criteria (27 listed)
- unable to provide Informed Consent or Patient History Form
- symptoms and signs of severe or complicated malaria including: continuous high fever over 39 °C, confusion, convulsions
- parasitemia<150.000 parasites /microliter
- other neurological or psychiatric symptoms or disorders
- abnormal bleeding
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 |
|---|---|---|
| ImatinibAlso: Gleevec, Glivectriple combination for the treatment of malaria | Drug | imatinib-Dihydroartemisinin-piperaquine |
| Dihydroartemisinin-piperaquineAlso: Artekin, Eurartesim, Diphos, Timequinstandard malaria treatment | Drug | Dihydroartemisinin-piperaquine |
Primary outcome
Occurrence of Adverse Events
Time frame: From baseline to day 42
Occurrence of Adverse Events over 42 days observation period
Occurrence of Severe Adverse Events
Time frame: From baseline to day 42
Occurrence of Severe Adverse Events over 42 days observation period
Occurrence of Abnormal Physical Symptoms
Time frame: From baseline to day 42
Occurrence of Abnormal Physical Symptoms (Clinical Abnormalities) over 42 days observation period
Occurrence of Abnormal Laboratory Values
Time frame: From baseline to day 42
Occurrence of Abnormal Laboratory Values over 42 days observation period
4 secondary outcomes
Frequency of residual parasitemia: % of patients with >1000 parasites/ ul at day 3 and 28
Time frame: day 3 and day 28
Frequency of fever and malaria symptoms
Time frame: day 3 and day 28
Mean parasitemia in the control and investigational arms
Time frame: day 2 and day 5
Parasite half-life measured at 12 and 24 hours
Time frame: from baseline to 24 hours post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Huynh D Chien, MD, PhD principal investigator
UNIVERSITY OF HUE, VIETNAM AND VINMEC DANANG INTERNATIONAL HOSPITAL, Hai Chau, Danang.
Francesco M Turrini, MD, PhD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib and Dihydroartemisinin-piperaquine in people with Plasmodium Falciparum Malaria (Drug Resistant), run by Nurex S.r.l. at 1 site in Vietnam.
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 4 inclusion and 27 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 5 Oct 2018. 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 Vietnam. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huynh D Chien, MD,PhD (+84903580518, huynhdinhchien55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Adverse Events (time frame: From baseline to day 42). The study lists 4 primary outcomes in all. 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 5 Oct 2018.