Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites

NCT ID: NCT03697668

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-17
• Study Completion Date: 2019-12-31

Brief 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.

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.

Conditions

Plasmodium Falciparum Malaria (Drug Resistant)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

imatinib-Dihydroartemisinin-piperaquine

triple combination

Group Type: EXPERIMENTAL

Imatinib

Intervention Type: DRUG

triple combination for the treatment of malaria

Dihydroartemisinin-piperaquine

standard of care

Group Type: ACTIVE_COMPARATOR

Dihydroartemisinin-piperaquine

Intervention Type: DRUG

standard malaria treatment

Interventions

Imatinib

triple combination for the treatment of malaria

Intervention Type: DRUG

Dihydroartemisinin-piperaquine

standard malaria treatment

Intervention Type: DRUG

Other Intervention Names

Gleevec; Glivec; Artekin; Eurartesim; Diphos; Timequin; Duocotecxin

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with mild to moderate P. falciparum malaria

2. Adult male, age 18-55 years

3. Good health conditions other than malaria

4. The patient did not take anti-malarial drugs in the past 4 weeks

Exclusion Criteria

1. unable to provide Informed Consent or Patient History Form

2. symptoms and signs of severe or complicated malaria including: continuous high fever over 39 °C, confusion, convulsions

3. parasitemia<150.000 parasites /microliter

4. other neurological or psychiatric symptoms or disorders

5. abnormal bleeding

6. resting hearth rate lower than 60 and higher than 100 bpm

7. abnormal ECG, history of cardiac diseases

8. male adults with corrected QT intervals > 450ms

9. signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system

10. hemoglobin < 9.0 gm/100ml

11. symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.

12. patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption

13. concomitant infection by plasmodium species other than P. falciparum

14. inability to meet daily with local doctor during period of clinical trial

15. concomitant medicines like:

1. medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin, simvastatin);

2. medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);

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);

4. medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);

5. medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;

6. medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital), carbamazepine or phenytoin;

7. medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);

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);

9. paracetamol (used to treat pain and fever);

10. theophylline (used to improve bronchial air flow);

11. nefazodone (used to treat depression);

12. aprepitant (used to treat nausea);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Sassari

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: collaborator

Vinmec Healthcare System

OTHER

Sponsor Role: collaborator

Nurex S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huynh D Chien, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY OF HUE, VIETNAM AND VINMEC DANANG INTERNATIONAL HOSPITAL, Hai Chau, Danang.

Francesco M Turrini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

A Tuc

Hương Hóa, Quang Tri, Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Huynh D Chien, MD,PhD

Role: CONTACT

huynhdinhchien55@gmail.com

+84903580518

Tran A Tuan, MD

Role: CONTACT

tuanhuonghoa@gmail.com

+84982290426

Facility Contacts

Tuan A Tran, MD

Role: primary

tuanhuonghoa@gmail.com

+84982290426

Other Identifiers

NUREX S.r.l

Identifier Type: -

Identifier Source: org_study_id