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

Malaria, Falciparum Clinical Trial

Official title:

Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389439
• Other study ID #: Cambodia1
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: April 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 1, 2016
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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 ß 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.

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Pyronaridine-artesunate

Locations

Country	Name	City	State
Cambodia	Tasanh Health Centre, Battambang	Battambang
Cambodia	Referral hospital (Pailin)	Pailin
Cambodia	Promoy Health Centre (Pursat)	Pursat)

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	NCHADS - Ministry of Health of Cambodia

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	result of PCR		42 day
Secondary	hepatic biological values	the hepatic biological values will be measured which are AST,ALT,albumin and total bilirubin	at day 0, 3,7 and day 28
Secondary	eosinophil count		at day 0, 3, 7 and day 28
Secondary	K13 and pfmdr1 of P falciparum resistance		at day 0, 3, 7 and day 28
Secondary	numbers of patients with a positive malaria slide 72 hours after treatment initiation		72 hours
Secondary	fever clearance time	the time taken for tympanic temperature to fall below 37.5°C and remain there for at least 24 hours	24 hours
Secondary	Number of patient with reinfection and recrudescences		over 42 days
Secondary	PCR uncorrected ACPR	PCR uncorrected ACPR at 28 days or 42 days for P. falciparum, P. falciparum and mixed infections in Pailin	at 28 days or 42 days
Secondary	PCR corrected ACPR	PCR corrected ACPR at 28 days or for P. falciparum, P. vivax and mixed infections and at 42 days for P. falciparum and mixed infections	at 28 days and 42 days
Secondary	Gametocyte carriage rates		at day 0, 3, 7 day 28
Secondary	gametocyte clearance times		at day 0, 3, 7 and day28