Trial | NCT03697668  Report issue

Title

Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites
Triple Antimalarial Combination (Imatinib-DHA-PPQ) to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
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 Started
Sep 17
2017
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Oct 05
2018

Drug Imatinib

triple combination for the treatment of malaria

  • Other names: Gleevec, Glivec

Drug Dihydroartemisinin-piperaquine [dihydroartemisinin, piperaquine]

standard malaria treatment

  • Other names: Artekin, Eurartesim, Diphos, Timequin, Duocotecxin

imatinib-Dihydroartemisinin-piperaquine Experimental

triple combination

Dihydroartemisinin-piperaquine Active Comparator

standard of care

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
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);
No Results Posted