Clinical trial

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients

NCT04411836

Name

EFFORT

Description

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

Trial arms

Trial start

2021-04-25

Estimated PCD

2024-09-30

Trial end

2024-09-30

Status

Recruiting

Phase

Early phase I

Treatment

Tafenoquine

patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).

Arms:

TQ Intervention

Primaquine

patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Arms:

PQ Intervention

Other names:

Primaquine 7 days

Size

960

Primary endpoint

Incidence risk any P vivax PQ7 / PQ14

6 months

Eligibility criteria

Inclusion Criteria * P. vivax peripheral parasitaemia (mono-infection) as determined by microscopy * G6PD normal status (G6PD activity ≥ 70% of the adjusted male median as determined by the Biosensor™ (SD Biosensor, ROK)) * Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours * Age ≥18 years * Written informed consent * Living in the study area and willing to be followed for six months Exclusion Criteria: * Danger signs or symptoms of severe malaria * Anaemia (defined as Hb \<8g/dl) * Pregnant or lactating females * Known hypersensitivity to any of the study drugs * Regular use of drugs with haemolytic potential

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 960, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

2 products

4 indications

Organization

Menzies School of Health Research

Product

Tafenoquine

Indication

Malaria caused by Plasmodium vivax

Indication

Indication

Indication

Product