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| Name | Class |
|---|---|
| University of Melbourne | OTHER |
| Fundação de Medicina Tropical Dr. Heitor Vieira Dourado | OTHER |
| Arba Minch University | OTHER |
| Addis Ababa University |
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The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question[s] it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQRevised | Experimental | Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg) |
|
| TQStandard | Active Comparator | Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard) |
|
| PQ7 | Experimental | Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafenoquine | Drug | oral treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence risk of vivax parasitaemia | The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy.
| 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence risk of vivax parasitaemia | The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy compared between TQStandard and PQ7 | 4 months |
| The incidence risk of symptomatic vivax parasitaemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hellen Mnjala | Contact | +610889468675 | hellen.mnjala@menzies.edu.au | |
| kamala K Thriemer | Contact | +610889468644 | kamala.ley-thriemer@menzies.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Kamala N Thriemer, PhD | Menzies School of Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Marcus Lacerda | Recruiting | Manaus | Brazil | |||
| Arba Minch General Hospital |
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| ID | Term |
|---|---|
| D016780 | Malaria, Vivax |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C055852 | tafenoquine |
| D011319 | Primaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| OTHER |
| Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia | UNKNOWN |
| Curtin University | OTHER |
| Papua New Guinea Institute of Medical Research | OTHER_GOV |
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| Primaquine |
| Drug |
oral treatment |
|
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy |
| 4 months |
| The incidence risk of vivax parasitaemia | The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy | 6 months |
| The incidence risk of symptomatic vivax parasitaemia | The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy | 6 months |
| The incidence rate of vivax parasitaemia | The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy | 6 months |
| The incidence rate of symptomatic vivax parasitaemia | The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy | 6 months |
| The incidence risk of anaemia | The incidence risk of developing severe anaemia (Hb < 5g/dl) or moderate (5g/dl and <7g/dl) anaemia within 7 and 14 days of starting treatment and/or requiring blood transfusion within the 6 months follow up period | 7 and 14 days, 6 months |
| The incidence risk of an acute drop in Hb | The incidence risk of an acute drop in Hb of >25% to <7g/dl within 7 and 14 days of starting treatment | 7 and 14 days |
| Adverse events | The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment | 42 days |
| Meth Hb concentration | day 7 methaemoglobin concentration | day 7 |
| Recruiting |
| Arba Minch |
| Ethiopia |
|
| Puskesmas Hanura | Not yet recruiting | Hanura | Indonesia |
|
| Dr Moses Laman and Dr Brioni Moore | Recruiting | Alexishafen | Papua New Guinea |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |