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

NCT03697668 | Unknown Phase 2

• 1 other identifier: NUREX S.r.l
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasmodium Falciparum Malaria (Drug Resistant)

Keywords

Imatinib Mesylate; piperaquine phosphate; dihydroartemisinin

Outcome Measures

Primary Outcomes (4)

• Occurrence of Adverse Events

  Occurrence of Adverse Events over 42 days observation period

  From baseline to day 42

• Occurrence of Severe Adverse Events

  Occurrence of Severe Adverse Events over 42 days observation period

  From baseline to day 42

• Occurrence of Abnormal Physical Symptoms

  Occurrence of Abnormal Physical Symptoms (Clinical Abnormalities) over 42 days observation period

  From baseline to day 42

• Occurrence of Abnormal Laboratory Values

  Occurrence of Abnormal Laboratory Values over 42 days observation period

  From baseline to day 42

Secondary Outcomes (4)

• Frequency of residual parasitemia: % of patients with >1000 parasites/ ul at day 3 and 28

  day 3 and day 28

• Frequency of fever and malaria symptoms

  day 3 and day 28

• Mean parasitemia in the control and investigational arms

  day 2 and day 5

• Parasite half-life measured at 12 and 24 hours

  from baseline to 24 hours post-treatment

Study Arms (2)

imatinib-Dihydroartemisinin-piperaquine

EXPERIMENTAL

triple combination

Drug: Imatinib

Dihydroartemisinin-piperaquine

ACTIVE COMPARATOR

standard of care

Drug: Dihydroartemisinin-piperaquine

Interventions

Imatinib DRUG

triple combination for the treatment of malaria

Also known as: Gleevec, Glivec

imatinib-Dihydroartemisinin-piperaquine

Dihydroartemisinin-piperaquine DRUG

standard malaria treatment

Also known as: Artekin, Eurartesim, Diphos, Timequin, Duocotecxin

Dihydroartemisinin-piperaquine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Nurex S.r.l.: lead
• Università degli Studi di Sassari: collaborator
• Purdue University: collaborator
• Vinmec Healthcare System: collaborator

Study Sites (1)

A Tuc

Hương Hóa, Quang Tri, 520000, Vietnam

RECRUITING

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Imatinib Mesylate; benzene-1,4-diphosphonic acid

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Huynh D Chien, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Francesco M Turrini, MD, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huynh D Chien, MD,PhD

CONTACT

+84903580518; huynhdinhchien55@gmail.com

Tran A Tuan, MD

CONTACT

+84982290426; tuanhuonghoa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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. In all phases, patients will be treated by a triple combination IMA-DHA-PPQ (ARM 1) or by the standard DHA-PPQ treatment (ARM 2).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: interventional

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: October 5, 2018
• Study Start: September 17, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)