Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-22 @ 2:45 PM
Study NCT ID:
NCT03697668
Status:
UNKNOWN
Last Update Posted:
2018-10-05
First Post:
2018-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'C064909', 'term': 'benzene-1,4-diphosphonic acid'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The research method will be a Phase 2 trial, 2 arms, randomized, open label (only the microscopist will be blinded), adaptive, dose de-escalation, trial conducted in adult male subjects with uncomplicated P.falciparum malaria.\n\nIn all phases, patients will be treated by a triple combination IMA-DHA-PPQ (ARM 1) or by the standard DHA-PPQ treatment (ARM 2).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'interventional'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Adverse Events', 'timeFrame': 'From baseline to day 42', 'description': 'Occurrence of Adverse Events over 42 days observation period'}, {'measure': 'Occurrence of Severe Adverse Events', 'timeFrame': 'From baseline to day 42', 'description': 'Occurrence of Severe Adverse Events over 42 days observation period'}, {'measure': 'Occurrence of Abnormal Physical Symptoms', 'timeFrame': 'From baseline to day 42', 'description': 'Occurrence of Abnormal Physical Symptoms (Clinical Abnormalities) over 42 days observation period'}, {'measure': 'Occurrence of Abnormal Laboratory Values', 'timeFrame': 'From baseline to day 42', 'description': 'Occurrence of Abnormal Laboratory Values over 42 days observation period'}], 'secondaryOutcomes': [{'measure': 'Frequency of residual parasitemia: % of patients with >1000 parasites/ ul at day 3 and 28', 'timeFrame': 'day 3 and day 28', 'description': 'Parasitemia is determined by assessing the parasite count in blood, using thin film, thick film and qPCR analysis.'}, {'measure': 'Frequency of fever and malaria symptoms', 'timeFrame': 'day 3 and day 28', 'description': 'Percentage of patients with fever or malaria symptoms observed at Phisical Visit at day 3 and 28.'}, {'measure': 'Mean parasitemia in the control and investigational arms', 'timeFrame': 'day 2 and day 5', 'description': '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'}, {'measure': 'Parasite half-life measured at 12 and 24 hours', 'timeFrame': 'from baseline to 24 hours post-treatment', 'description': 'Mean parasite clearance half-life calculated using parasitemia measured at baseline, 12 and 24 hours post-treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imatinib Mesylate', 'piperaquine phosphate', 'dihydroartemisinin'], 'conditions': ['Plasmodium Falciparum Malaria (Drug Resistant)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe slow and incomplete clearance of parasites following ACT treatment is considered to permit the selection of resistant parasites.\n\nThe availability of new, more efficient treatments accelerating the clearance of parasites is therefore needed to counteract the selection of ART resistant strains.\n\nImatinib (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.\n\nIMA 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with mild to moderate P. falciparum malaria\n2. Adult male, age 18-55 years\n3. Good health conditions other than malaria\n4. The patient did not take anti-malarial drugs in the past 4 weeks\n\nExclusion Criteria:\n\n1. unable to provide Informed Consent or Patient History Form\n2. symptoms and signs of severe or complicated malaria including: continuous high fever over 39 °C, confusion, convulsions\n3. parasitemia\\<150.000 parasites /microliter\n4. other neurological or psychiatric symptoms or disorders\n5. abnormal bleeding\n6. resting hearth rate lower than 60 and higher than 100 bpm\n7. abnormal ECG, history of cardiac diseases\n8. male adults with corrected QT intervals \\> 450ms\n9. signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system\n10. hemoglobin \\< 9.0 gm/100ml\n11. symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.\n12. patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption\n13. concomitant infection by plasmodium species other than P. falciparum\n14. inability to meet daily with local doctor during period of clinical trial\n15. concomitant medicines like:\n\n 1. medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin, simvastatin);\n 2. medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);\n 3. 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);\n 4. medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);\n 5. medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;\n 6. medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital), carbamazepine or phenytoin;\n 7. medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);\n 8. 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);\n 9. paracetamol (used to treat pain and fever);\n 10. theophylline (used to improve bronchial air flow);\n 11. nefazodone (used to treat depression);\n 12. aprepitant (used to treat nausea);'}, 'identificationModule': {'nctId': 'NCT03697668', 'acronym': 'Artesynib', 'briefTitle': 'Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nurex S.r.l.'}, 'officialTitle': 'Triple Antimalarial Combination (Imatinib-DHA-PPQ) to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites', 'orgStudyIdInfo': {'id': 'NUREX S.r.l'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'imatinib-Dihydroartemisinin-piperaquine', 'description': 'triple combination', 'interventionNames': ['Drug: Imatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dihydroartemisinin-piperaquine', 'description': 'standard of care', 'interventionNames': ['Drug: Dihydroartemisinin-piperaquine']}], 'interventions': [{'name': 'Imatinib', 'type': 'DRUG', 'otherNames': ['Gleevec', 'Glivec'], 'description': 'triple combination for the treatment of malaria', 'armGroupLabels': ['imatinib-Dihydroartemisinin-piperaquine']}, {'name': 'Dihydroartemisinin-piperaquine', 'type': 'DRUG', 'otherNames': ['Artekin', 'Eurartesim', 'Diphos', 'Timequin', 'Duocotecxin'], 'description': 'standard malaria treatment', 'armGroupLabels': ['Dihydroartemisinin-piperaquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '520000', 'city': 'Hương Hóa', 'state': 'Quang Tri', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Tuan A Tran, MD', 'role': 'CONTACT', 'email': 'tuanhuonghoa@gmail.com', 'phone': '+84982290426'}], 'facility': 'A Tuc', 'geoPoint': {'lat': 16.61667, 'lon': 106.75}}], 'centralContacts': [{'name': 'Huynh D Chien, MD,PhD', 'role': 'CONTACT', 'email': 'huynhdinhchien55@gmail.com', 'phone': '+84903580518'}, {'name': 'Tran A Tuan, MD', 'role': 'CONTACT', 'email': 'tuanhuonghoa@gmail.com', 'phone': '+84982290426'}], 'overallOfficials': [{'name': 'Huynh D Chien, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIVERSITY OF HUE, VIETNAM AND VINMEC DANANG INTERNATIONAL HOSPITAL, Hai Chau, Danang.'}, {'name': 'Francesco M Turrini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turin, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nurex S.r.l.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Università degli Studi di Sassari', 'class': 'OTHER'}, {'name': 'Purdue University', 'class': 'OTHER'}, {'name': 'Vinmec Healthcare System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}