Trial · NCT01814683
IMPROV (Improving the Radical Cure of Vivax Malaria)
NCT01814683, Not applicable, Completed, University of Oxford
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IMPROV (Improving the Radical Cure of Vivax Malaria). Trials, record NCT01814683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01814683
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IMPROV (Improving the Radical Cure of Vivax Malaria)
- NCT number
- NCT01814683
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,388 participants, actual
- Lead sponsor
- University of Oxford
- Conditions
- Uncomplicated Vivax Malaria
- Interventions
- Primaquine, Primaquine, Placebo
- First posted
- 2013-03-20
- Last updated
- 2019-09-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence rate (per person-year) of symptomatic recurrent P. vivax | 12 months | The incidence rate (i.e. per person-year) of symptomatic recurrent P. vivax parasitaemia (detected by microscopy) over 12 months of follow-up in the 7 versus 14-day primaquine groups for all sites combined and stratified by site. |
| Secondary | The incidence rate (per person-year) of any recurrent P. vivax malaria. | 12 months | The incidence rate (per person-year) of any recurrent (i.e. symptomatic and asymptomatic) P. vivax parasitaemia over 12 months of follow-up in the 7 and 14-day primaquine regimens for all sites combined and stratified by site. |
| Secondary | Incidence risk of any recurrent symptomatic of P. vivax malaria compared to control arm | 12 months | The incidence rate (per person-year) of any recurrent symptomatic P. vivax parasitaemia over 12 months of follow-up in either the 7 or the 14-day primaquine regimens compared with the control arm, for all sites combined and stratified by site. |
| Secondary | The Haematological recovery in patients with vivax malaria | 12 months | Haematological recovery will be assessed as the incidence risk of severe anaemia (Hb\<7g/dl) and/or blood transfusion within the 12 month follow up period, and the mean fall in baseline Hb at day 7 and day 14. These outcomes will be compared between the intervention arms and also between each intervention arm and the controls. |
| Secondary | Proportion of patients with Serious Adverse Drug reactions | 12 months | The proportion of patients with one or more serious adverse drug reactions within 42 days of their primary treatment and also at 6 and 12 months. |
| Secondary | Primaquine tolerability | 14 days | Tolerability of primaquine will be assessed by comparing the proportion of patients with nausea, vomiting, abdominal pain and vomiting of a dose within 1 hour of administration between the intervention arms and also between each intervention arm and the controls. |
| Secondary | Primaquine tolerability comparison between patients in intervention arm and control arm | 14 days | Drug tolerability will be assessed also by comparing the proportion of patients completing a full course of observed primaquine therapy between the intervention arms and also between each intervention arm and the controls. |
| Secondary | Incidence risk of severe anaemia in G6PD deficient arm | 14 days | \- The G6PD deficiency treatment arm will provide important data on the safety and tolerability of the WHO recommended weekly regimen. The incidence risk of severe anaemia (Hb\<7g/dl) and/or requirement for blood transfusion within the 12 month follow up period and the mean fall in baseline Hb at day 7 and day 14 will be determined. |
| Secondary | Cost effective analysis in the management of P. vivax with respect to the use of G6PD tests | 12 months | The cost of illness will be compared between the intervention arms and also between each intervention arm and the controls. A cost-effectiveness analysis for the management of P. vivax with respect to the use of G6PD tests, the dosing schedule and the epidemiological context will be conducted. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01814683
GET https://conductscience.org/api/trials/v1/NCT01814683/registered