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Compares treatment options for Malaria, Vivax
Official title An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
ClinicalTrials.gov ID: NCT06666491
What this study is testing
What is Tafenoquine?
Tafenoquine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malaria, vivax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 64
You may be able to join if
- Males and females \>=2 years of age and under (\ 10 kg.
- The participant has a positive malarial smear for P. vivax with a parasite density of \>100/microliter and \<100,000/microliter.
- The participant has a screening Hb value \>8 g/dL.
- The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
- The participant has a G6PD value (measured using the SD Biosensor STANDARDTM G6PD test) 6.1 units/gram (U/g) Hb for G6PD activity (6.1 U/g Hb cut-off...
You likely can't join if
- The participant has severe P. vivax malaria as defined by WHO criteria [WHO, 2023].
- The participant has a mixed malaria infection (identified by a malarial smear).
- The participant has a condition that may affect absorption of study medication, such as severe vomiting (no food or inability to take food during the...
- The participant has a history of porphyria, psoriasis, or epilepsy.
- The participant has a history of allergy, intolerance to or a known contraindication to the use of mefloquine (or other aryl amino alcohol drugs)...
- The participant has received treatment with any investigational drug within 30 days of study entry, or within 5 half-lives, whichever is longer.
See the full eligibility criteria
- Males and females \>=2 years of age and under (\ 10 kg.
- The participant has a positive malarial smear for P. vivax with a parasite density of \>100/microliter and \<100,000/microliter.
- The participant has a screening Hb value \>8 g/dL.
- The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
- The participant has a G6PD value (measured using the SD Biosensor STANDARDTM G6PD test) 6.1 units/gram (U/g) Hb for G6PD activity (6.1 U/g Hb cut-off is applicable for both males and females).
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and if one of the following conditions applies:
- Is a woman of non-childbearing potential (WONCBP) as defined in
- Is a Women of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, during the study intervention period and for at...
- A WOCBP must test negative on a highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.
- The participant is willing and able to comply with the procedures described in the study protocol. The participant or parent/legal guardian, as applicable, has given written informed, dated consent; and the participant...
- The participant has severe P. vivax malaria as defined by WHO criteria [WHO, 2023].
- The participant has a mixed malaria infection (identified by a malarial smear).
- The participant has a condition that may affect absorption of study medication, such as severe vomiting (no food or inability to take food during the previous 8 hours).
- The participant has a history of porphyria, psoriasis, or epilepsy.
- The participant has a history of allergy, intolerance to or a known contraindication to the use of mefloquine (or other aryl amino alcohol drugs), chloroquine, tafenoquine, primaquine, any other 4- or 8-AQ or any of...
- The participant has received treatment with any investigational drug within 30 days of study entry, or within 5 half-lives, whichever is longer.
- The participant has previously enrolled in this study.
- The participant has a recent history of illicit drug abuse or heavy alcohol intake that in the opinion of the investigator could compromise full participation in the study or adherence to study procedures.
- Participants with a current or past history of serious psychiatric disorders.
- The participant has a clinically significant concurrent illness (e.g., pneumonia, tuberculosis, meningitis, septicemia, dengue, coagulopathy, severe hemorrhage, or febrile convulsions prior to consent) or a pre-existing...
- The participant is known to be HIV-infected and/or is currently on antiretroviral therapy.
- The participant is regularly using drugs with hemolytic potential.
- The participant has a QT corrected by Fridericia's formula (QTcF) \>450 msec, evidence of bradycardia (\ =6.0 mmol/L) at Screening.
- The participant has taken drugs with antimalarial activity (e.g., artemisinin-based combination therapies, mefloquine, primaquine, chloroquine, tafenoquine or any other 4-AQ) within 30 days prior to study entry.
- The participant has taken or will likely require during the study the use of:
- Histamine-2 blockers (restricted to first 3 days whilst receiving CQ)
- Antacids (restricted to first 3 days whilst receiving CQ)
- Drugs of the biguanide class (i.e., phenformin, metformin, buformin)
- Anti-arrhythmic agents (i.e., dofetilide, procainamide, pilsicainide)
- Medications that prolong the QTc interval
- The participant has liver transaminases (ALT/AST) \>2 times the upper limit of normal (ULN).
The study team makes the final eligibility decision.
Where it's taking place
- Ahmedabad, India
- Kolkata, India
- Mumbai, India
- Surat, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ahmedabad, India; Kolkata, India; Mumbai, India; Surat, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.