Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria

NCT ID: NCT02389439

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2016-06-01

Brief Summary

This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.

All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.

Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).

Conditions

Malaria, Falciparum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pyronaridine-artesunate

Pyronaridine-artesunate (Pyramax®, Shin Poong Pharmaceuticals). One tablet contains 60mg artesunate+ 180mg pyronaridine. Dosing will be according to body weight.

It will be taken orally with water, once daily for 3 days. Each dose will be administered under the supervision. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only.

20 - < 24 kg = 1 tab 24 - < 45 kg = 2 tabs 45 - < 65 kg = 3 tabs 65 and above = 4 tabs

Group Type: EXPERIMENTAL

Pyronaridine-artesunate

Intervention Type: DRUG

Interventions

Pyronaridine-artesunate

Intervention Type: DRUG

Other Intervention Names

Pyramax

Eligibility Criteria

Inclusion Criteria

• Adults and children ≥ 20 kg
• Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever >37.5°c.
• Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
• Capability of taking an oral medication
• Written informed consent given to participate in the trial
• Willingness and ability to adhere to follow-up visit schedule

Exclusion Criteria

• Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age, that is 18 to 45 y/o)
• Female aged 12-18y
• Parasitemia > 150 000/µL).
• Signs or symptoms indicative of severe malaria:

• Impaired consciousness (Blantyre Coma Score <5)
• Severe anaemia (Hct<15%)
• Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites
• Respiratory distress
• Severe jaundice
• Known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or to pyronaridine
• History of splenectomy
• Known history or evidence of clinically significant disorders, such as:

• Known active Hepatitis A, e.g. by detection of anti HAV-IgM.
• Known hepatitis B surface antigen (HBsAg) carrier.
• Known hepatitis C antibody (HCV Ab).
• Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range.

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NCHADS - Ministry of Health of Cambodia

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tasanh Health Centre, Battambang

Battambang, , Cambodia

Referral hospital (Pailin)

Pailin, , Cambodia

Promoy Health Centre (Pursat)

Pursat, , Cambodia

Countries

Cambodia

References

Leang R, Canavati SE, Khim N, Vestergaard LS, Borghini Fuhrer I, Kim S, Denis MB, Heng P, Tol B, Huy R, Duparc S, Dondorp AM, Menard D, Ringwald P. Efficacy and Safety of Pyronaridine-Artesunate for Treatment of Uncomplicated Plasmodium falciparum Malaria in Western Cambodia. Antimicrob Agents Chemother. 2016 Jun 20;60(7):3884-90. doi: 10.1128/AAC.00039-16. Print 2016 Jul.

Reference Type: DERIVED

PMID: 26926629 (View on PubMed)

Other Identifiers

Cambodia1

Identifier Type: -

Identifier Source: org_study_id