Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam

Plasmodium Vivax Malaria Clinical Trial

Official title:

A Randomised Controlled Trial to Assess the Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887821
• Other study ID #: 07MA
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2013
• Last updated: September 29, 2016
• Start date: February 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2014
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Viet Nam: Institute of Malaria, Parasitology and Entomology, Ho Chi Minh City
• Study type: Interventional

Clinical Trial Summary

This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam.

Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other.

Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment.

The results of the study will be used to inform malaria treatment guidelines in Viet Nam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Age > 3 years;

• Mono-infection with P. vivax, parasitemia > 250/µl asexual forms for in vivo and >8000 asexual parasites/µl blood for in vitro testing;

• Presence of axillary or tympanic temperature = 37.5 °C or history of fever during the past 24 h;

• Ability to swallow oral medication;

• Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;

• Informed consent/assent

Exclusion Criteria:

• Presence of general danger signs or severe malaria according to the definitions of WHO (2000);

• Mixed infection with P.falciparum and P.vivax of other plasmodium species;

• Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);

• Regular medication, which may interfere with antimalarial pharmacokinetics;

• Received antimalarial drugs in the previous 48 hours;

• History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

• Splenectomy;

• First trimester of pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease Susceptibility
• Malaria
• Malaria, Vivax
• Plasmodium Vivax Malaria

Intervention

Drug:
• Chloroquine

• Dihydroartemisinin/Piperaquine

Locations

Country	Name	City	State
Vietnam	Bu Gia Map Health Station	Bu Gia Map	Binh Phuoc

Sponsors (5)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Agency for Science, Technology and Research, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Institute of Malaria, Parasitology and Entomology, Ho Chi Minh City, Viet Nam, Wellcome Trust

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with adequate response to treatment	Adequate response = adequate clinical and parasitological response. Absence of parasitaemia on day 63, irrespective of temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.	Day 63	No
Secondary	Proportion of patients classified as Early Treatment Failures	One or more of the following: danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia; parasitaemia on day 2 higher than on day 0, irrespective of temperature; parasitaemia on day 3 with temperature = 37.5 ºC; parasitaemia on day 3 = 25% of count on day 0.	Day 63	No
Secondary	The parasite clearance time	Defined as the time in hours from the first treatment dose to the first of two consecutive parasitemia counts of zero.	Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.	No
Secondary	Fever clearance time	Defined as the time in hours from the first treatment dose to the start of the first sustained period of 24 hours without fever	Assessed every 6 hours until Day 3, or 24 hours without fever	No
Secondary	Frequency of adverse and serious adverse events		Day 63	No
Secondary	Proportion of patients classified as Late Clinical Failures	One or more of the following: danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 63 in patients who did not previously meet any of the criteria of early treatment failure; presence of parasitaemia on any day between day 4 and day 63 with temperature = 37.5 ºC (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure	Day 63	No
Secondary	Proportion of patients classified as Late Parasitological Failures	Presence of parasitaemia on any day between day 7 and day 63 with temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure	Day 63	No

External Links

•   Oxford University Clinical Research Unit, Viet Nam