P.Vivax Treatment Trial

Plasmodium Vivax Clinical Trial

— Lao Pv  

Official title:

A Randomised, Single-blinded Controlled Treatment Trial of Subclinical Vivax Infections With Primaquine in Nong Province, Laos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802813
• Other study ID #: LOMWRU1601
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 14, 2016
• Est. completion date: June 15, 2018

Study information

• Verified date: August 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).

Description:

This is a randomized, Single blind trial in G6PD normal participants with subclinical P. vivax infections in Laos. Participants with subclinical P. vivax infections and those meeting the enrolment criteria will be randomly assigned to one of two treatment arms: - Intervention: Dihydroartemisinin-piperaquine (DP) therapy 3 days dosing plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg/day). - Control arm: Dihydroartemisinin-piperaquine (DP) 3 days dosing therapy plus 14 days identical primaquine placebo. Participants found to be G6PD deficient (G6PDd) will be treated with primaquine 0.75mg/kg/week for 8 weeks according to WHO recommendations. Primaquine and placebo will be administered with food (biscuits), which has been shown to reduce gastrointestinal side effects. All doses of study drugs will be supervised. If participants cannot visit the study centre, or fail to attend during the 14 days of supervised therapy, team members will visit them in their homes, schools or work to ensure complete dosing. Findings: The study showed that a 14-day course of primaquine added to mass drug administration with dihydroartemisinin-piperaquine prevented recurrent asymptomatic P. vivax infections (doi: 10.1186/s12936-019-3091-5)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Participants with subclinical mono- or mixed P. vivax infections (uPCR) can be enrolled.
• Able to participate as decided by the investigators, and willing to comply with the study requirements and follow-up.
• A participant (or parent/guardian of children below age of consent) is willing and able to give written informed consent to participate in the trial.

Exclusion Criteria:

• Currently pregnant or breastfeeding (female of child-bearing age).
• Inability to tolerate oral treatment.
• Previous episode of haemolysis or severe haemoglobinuria following primaquine.
• Known hypersensitivity or allergy to the study drugs.
• Blood transfusion in last 90 days, since this can mask G6PD deficiency.
• An acute malaria episode requiring treatment.
• A febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration).
• Anaemia (Haemoglobin (Hb) < 9 g/dL
• Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal or hepatic disease; severe malnutrition; HIV/AIDS; or severe febrile condition other than malaria); co-administration of other medication known to cause haemolysis or that could interfere with the assessment of antimalarial regimens.
• Currently taking medication known to interfere significantly with the pharmacokinetics of primaquine and the schizontocidal study drugs

Related Conditions & MeSH terms

• Malaria
• Plasmodium Vivax

Intervention

Drug:
• Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ)

• Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) placebo

Locations

Country	Name	City	State
Lao People's Democratic Republic	Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit	Vientiane

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Mahidol Oxford Tropical Medicine Research Unit

Country where clinical trial is conducted

Lao People's Democratic Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence rate of P. vivax parasitaemia in G6PD-normal participants	the incidence rate will be detected by uPCR	over 12 months
Secondary	Time to P. vivax clearance	Detected by uPCR	12 months
Secondary	The frequency of recurrent vivax infections (clinical and sub-clinical)		12 months
Secondary	The follow-up period required to detect a statistically significant difference in the frequency of recurrent subclinical P. vivax infections between treated and untreated participants	measured by uPCR	12 months
Secondary	Number of participants with treatment related Adverse event.		28 days
Secondary	Number of participants with treatment related malaria episode		12 months
Secondary	Number of doses taken per participants		14 days
Secondary	Compare the percentage decrease in hemoglobin between those who receive primaquine and who those not receive primaquine		12 months
Secondary	Number of G6PD genotypes in participants with G6PD deficiency		12 months
Secondary	Number of P450 genotypes in participants with recurrent PV infection.		12 months