P.Vivax Treatment Trial

NCT02802813 | Completed Phase 1

• 1 other identifier: LOMWRU1601
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Plasmodium Vivax

Keywords

Single-blinded controlled trial; Primaquine

Outcome Measures

Primary Outcomes (1)

• The incidence rate of P. vivax parasitaemia in G6PD-normal participants

  the incidence rate will be detected by uPCR

  over 12 months

Secondary Outcomes (9)

• Time to P. vivax clearance

  12 months

• The frequency of recurrent vivax infections (clinical and sub-clinical)

  12 months

• 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

  12 months

• Number of participants with treatment related Adverse event.

  28 days

• Number of participants with treatment related malaria episode

  12 months

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Dihydroartemisinin-piperaquine (DP) therapy plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg).

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

Control arm

PLACEBO COMPARATOR

Dihydroartemisinin-piperaquine therapy plus 14 days identical placebo not containing primaquine.

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

Interventions

Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) DRUG

Intervention arm

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

Control arm

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator

Study Sites (1)

Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit

Vientiane, Laos

Location

Related Publications (2)

• Phommasone K, van Leth F, Imwong M, Henriques G, Pongvongsa T, Adhikari B, Peto TJ, Promnarate C, Dhorda M, Sirithiranont P, Mukaka M, Peerawaranun P, Day NPJ, Cobelens F, Dondorp AM, Newton PN, White NJ, von Seidlein L, Mayxay M. The use of ultrasensitive quantitative-PCR to assess the impact of primaquine on asymptomatic relapse of Plasmodium vivax infections: a randomized, controlled trial in Lao PDR. Malar J. 2020 Jan 3;19(1):4. doi: 10.1186/s12936-019-3091-5.

  PMID: 31900172 DERIVED

• von Seidlein L, Peerawaranun P, Mukaka M, Nosten FH, Nguyen TN, Hien TT, Tripura R, Peto TJ, Pongvongsa T, Phommasone K, Mayxay M, Imwong M, Watson J, Pukrittayakamee S, Day NPJ, Dondorp AM. The probability of a sequential Plasmodium vivax infection following asymptomatic Plasmodium falciparum and P. vivax infections in Myanmar, Vietnam, Cambodia, and Laos. Malar J. 2019 Dec 30;18(1):449. doi: 10.1186/s12936-019-3087-1.

  PMID: 31888643 DERIVED

MeSH Terms

Conditions

Malaria, Vivax

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mayfong Mayxay, MD

  Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 16, 2016
• Study Start: June 14, 2016
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: March 2, 2022

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

LA (1)