Safety, Tolerability, Pharmacokinetics and Efficacy, Phase Iv, Open Label Study of Fixed Arco® and Eurartesim® Therapies in Adults and Children With Uncomplicated P. Falciparum Malaria in Tanzania

Ifakara Health Institute1 site in 1 country60 target enrollmentJanuary 7, 2014

ConditionsPlasmodium Falciparum Malaria, Falciparum

Interventionsartemisinin/naphthoquine dihydroartemisinin/piperaquine phosphate

Drugsartemisinin/naphthoquine dihydroartemisinin/piperaquine phosphate

Overview

Phase: Phase 4
Intervention: artemisinin/naphthoquine
Conditions: Plasmodium Falciparum
Sponsor: Ifakara Health Institute
Enrollment: 60
Locations: 1
Primary Endpoint: Number of reported non serious and serious adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Phase IV, single center, 2 arms randomized controlled, open label study. Study will be conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics and efficacy of ARCO.

Detailed Description

Evaluation of safety and tolerability of the administration of ARCO and Eurartesim in terms of blood biochemistry, full blood count, ECG assessments, vital signs and adverse events profile in patients with uncomplicated P. falciparum malaria. Dihydroartemisinin/piperaquine will be used as comparator.

Registry

clinicaltrials.gov

Start Date

January 7, 2014

End Date

June 1, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ifakara Health Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent, in accordance with local practice, provided by patient, for children it will provided by either parents or legal representative and in addition children will provide assent.
•Male or female patients between the age of 6 and 60 years (both inclusive)
•Body weight between 20 kg and 90 kg (both inclusive)
•Presence of mono-infection with P. falciparum (1,000 to 100,000 asexual count/µl of blood) microscopically confirmed.
•Fever, as defined by axillary temperature ≥ 37.5°C to ≤ 39.5°C
•Ability to swallow oral medication
•Ability and willingness to adhere to all study procedures and access health facilities.
•Agree to undergo study related procedures including being hospitalized for minimum of 3 days (0,1 and 2), and a follow up of up to 42 days.

Exclusion Criteria

•Patients with signs and symptoms of severe/complicated malaria as described in the WHO guideline(Third Edition 2012) for management of severe malaria(6)(Appendix 1)
•Mixed Plasmodial infection.
•Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment.
•Severe diarrhoea defined as 3 or more watery stools per day.
•Presence of other serious or chronic clinical condition requiring hospitalization.
•Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTcF or QTcB interval greater than or equal to 450 msec), respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological, neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions or other abnormality (including head trauma).
•Family history of sudden death or of congenital prolongation of the QT interval or any other clinical condition known to prolong the QT interval.
•Known congenital prolongation of the QT-interval or any clinical condition known to prolong the QT interval.
•History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
•Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.

Arms & Interventions

ARCO treatment

Patients in this treatment arm will receive on Day 0 a single dose of standard treatment of artemisinin/naphthoquine (in a fixed oral dose of ARCO tablets). Treatment will be given under supervision.

Intervention: artemisinin/naphthoquine

Eurartesim treatment

Patients in this treatment arm will receive a dose of dihydroartemisinin/piperaquine phosphate (in a fixed oral dose of Eurartesim tablets) over three days (0,1,2). Treatment will be given under supervision.

Intervention: dihydroartemisinin/piperaquine phosphate

Outcomes

Primary Outcomes

Number of reported non serious and serious adverse events

Time Frame: Up to 6 Weeks

Secondary Outcomes

12-lead ECG recordings: Heart rate, PR interval, QRS duration, QT interval, QTc (Fridericia and Bazett corrections), any T wave or U-wave morphology.(Holter recording will run continuously during 12 hours after the last dose of treatment)