Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05753150 |
| Other study ID # |
MMV_TQ_18_01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 23, 2022 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Ministry of Health, Thailand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this prospective, observational study is to assess the operational feasibility
of appropriate radical cure treatment for P. vivax malaria with tafenoquine or primaquine, in
patients 16 year and older, after G6PD testing in Thailand. The study will be implemented in
a phased manner, in the provinces of Yala and Mae Hong Son. The first phase will be at higher
level health facilities (hospitals). An interim analysis will be conducted after 40 patients
are enrolled in the study in order to decide whether the study could be extended to lower
level HFs. If approved by the Independent Study Oversight Committee, the study will be
implemented in lower level HFs (malaria clinics).Higher level HFs will continue to include
patients in the study during this 2nd phase.Written informed consent / assent is required
from all patients /guardians in the case of minors.
Description:
This is a prospective, observational, multi-center, longitudinal study to be conducted in
Yala province and Mae Hong Son province in patients with P. vivax malaria.
Since 2020, quantitative G6PD testing has been available for routine use prior to providing
PQ radical therapy at district hospitals and malaria clinics in the study provinces, in line
with the national guidelines.
Before study start, the relevant staff at all participating sites will be re-trained on the
quantitative G6PD test procedure and the radical cure treatment algorithm by the Division of
Vector Borne Diseases (DVBD). Standard operating procedures (SOP) for identification of
patients with suspected AHA and guidance for initial management and transfer to a referral
hospital will be provided.
G6PD tests and TQ will be supplied to Health Facilities (HFs) by the DVBD using the usual
supply route for drugs and diagnostics. PQ and other anti-malarial drugs are already
available in Thailand.
Within the study period, investigators will prospectively enroll all patients meeting the
selection criteria.
Each patient will have to sign an Informed Consent Form (ICF) indicating their consent for
participation in the study by being considered for treatment with TQ provided that they have
the appropriate G6PD enzyme activity (or treated with PQ, according to the current practice,
otherwise) and permitting investigators to use their unidentified data for analysis purposes.
Assent from patients <18 years of age, and the parent's or legal guardian's written informed
consent must be obtained.
This study will not change the patient/physician relationship, nor influence the
investigator's drug prescription or therapeutic management of the patient other than what is
specified regarding the algorithm for radical cure treatment of P. vivax malaria with TQ and
PQ.
As part of local practice in Yala province and Mae Hong Son province, patients treated for P.
vivax infection are asked to return for a follow-up visit on Day 5 (+/- 1 day). This is in
addition to the national policy of the first scheduled follow-up visit on Day 14 (+2/- 1 day)
for vivax malaria patients. Patient data will be collected by the investigators on each
patient visit.
Any suspected case of AHA will be transferred to Yala Referral Hospital, the regional
hospital with one board-certified haematologist or to the Mae Hong Son Provincial Hospital.
Both hospitals have full services of blood transfusion, renal dialysis, and other life-saving
procedures, for further investigation and treatment.
As some patients may not return for the follow-up visits and might develop drug-induced AHA,
the study staff at the referral hospitals will regularly screen hospital admission records
for malaria patients participating in the study presenting signs of AHA, diagnosed with renal
failure, and/or receiving blood transfusion.
The study will be conducted in 2 phases:
- 1st phase (for about 3 months): the study will be implemented in higher level HFs
(hospitals). An interim analysis will be conducted after 40 patients (≥16 years old)
with P. vivax are enrolled in the study in order to decide whether the study could be
extended to lower level HFs. The decision will be made by an Independent Study Oversight
Committee (ISOC).
- 2nd phase (approximately 2 months): if approved by the ISOC, the study will be
implemented in lower level HFs (malaria clinics).
Higher level HFs will continue to include patients in the study during this 2nd phase.
Final results will be reviewed by the ISOC. It is anticipated that it will take a total of
about 11-12 months to complete data collection at the target hospitals and malaria clinics.
