Trial · NCT04222088
TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
NCT04222088, Completed, Research Institute for Tropical Medicine, Philippines; results first posted 2023-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014. Trials, record NCT04222088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04222088
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
- NCT number
- NCT04222088
- Status
- Completed
- Enrollment
- 159 participants, actual
- Lead sponsor
- Research Institute for Tropical Medicine, Philippines
- Conditions
- Malaria, Falciparum Malaria, Vivax Malaria, Malaria Recrudescence
- Interventions
- Arthemeter-lumefantrine, Chloroquine, Primaquine
- First posted
- 2020-01-09
- Last updated
- 2023-07-21
- Results first posted
- 2023-02-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early Treatment Failure (ETF) | Day 1-3 | The classification of treatment outcomes will be based on an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest guidelines of WHO. Accordingly, all patients will be classified as having an Early Treatment Failure by microscopy results P without PCR correction * Development of danger signs or severe malaria on day 1, day 2, or day 3 in the presence of parasitemia; * Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature; * Parasitaemia on day 3 with axillary temperature ≥37.5 ºC; * Parasitaemia on day 3 ≥25% of count on day 0. |
| Primary | Late Clinical Failure (LCF) | Day 4-28 | Patients with late clinical failure without PCR correction: * Development of danger signs or severe malaria on any day from day 4 to day 28 in the presence of parasitaemia, without previously meeting any of the criteria of Early Treatment Failure; * Presence of parasitemia and axillary temperature ≥37.5 ºC (or history of fever in low/moderate transmission areas) on any day from day 4 to day 28, without previously meeting any of the criteria of Early Treatment Failure. |
| Primary | Late Parasitological Failure (LPF) | day 7 to day 28 | Patients with late parasitological failure without PCR correction: • Presence of parasitemia on any day from day 7 to day 28 and axillary temperature \<37.5 ºC, without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure. |
| Primary | Adequate Clinical and Parasitological Response (ACPR) | Day 0-28 | Adequate Clinical and Parasitological Response (ACPR): Absence of parasitemia on day 28 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Early Treatment Failure (ETF) | Day 1-3 | Analysis of population is categorically subdivided depending on the period of enrollment of participants to the study | participants | NUMBER |
| PRIMARY | Late Clinical Failure (LCF) | Day 4-28 | Analysis of population is categorically subdivided depending on the period of enrollment of participants in the study | participants | NUMBER |
| PRIMARY | Late Parasitological Failure (LPF) | day 7 to day 28 | Analysis of population is categorically subdivided depending on the period of enrollment of participants in the study | participants | NUMBER |
| PRIMARY | Adequate Clinical and Parasitological Response (ACPR) | Day 0-28 | Analysis of population is categorically subdivided depending on the period pf enrollment of the participant in the study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Early Treatment Failure (ETF) | Artemether-lumefantrine (Coartem™) + Primaquine | 0 | 95% Confidence Interval 0 to 4.8 | participants | |
| Early Treatment Failure (ETF) | Chloroquine + Primaquine | 0 | 95% Confidence Interval 0 to 4.9 | participants | |
| Late Clinical Failure (LCF) | Artemether-lumefantrine (Coartem™) + Primaquine | 1 | 95% Confidence Interval 0 to 7.2 | participants | |
| Late Clinical Failure (LCF) | Chloroquine + Primaquine | 0 | 95% Confidence Interval 0 to 4.9 | participants | |
| Late Parasitological Failure (LPF) | Artemether-lumefantrine (Coartem™) + Primaquine | 0 | 95% Confidence Interval 0 to 4.8 | participants | |
| Late Parasitological Failure (LPF) | Chloroquine + Primaquine | 2 | 95% Confidence Interval 0.3 to 9.4 | participants | |
| Adequate Clinical and Parasitological Response (ACPR) | Artemether-lumefantrine (Coartem™) + Primaquine | 74 | Participants | ||
| Adequate Clinical and Parasitological Response (ACPR) | Chloroquine + Primaquine | 72 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Artemether-lumefantrine (Coartem™) + Primaquine | 84 | |
| Overall Study | STARTED | Chloroquine + Primaquine | 75 | |
| Overall Study | COMPLETED | Artemether-lumefantrine (Coartem™) + Primaquine | 75 | |
| Overall Study | COMPLETED | Chloroquine + Primaquine | 74 | |
| Overall Study | NOT COMPLETED | Artemether-lumefantrine (Coartem™) + Primaquine | 9 | |
| Overall Study | NOT COMPLETED | Chloroquine + Primaquine | 1 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Artemether-lumefantrine (Coartem™) + Primaquine | 0 | 84 |
| Total, all-cause mortality | Chloroquine + Primaquine | 0 | 75 |
| Total, other adverse events | Artemether-lumefantrine (Coartem™) + Primaquine | 0 | 84 |
| Total, other adverse events | Chloroquine + Primaquine | 0 | 75 |
| Total, serious adverse events | Artemether-lumefantrine (Coartem™) + Primaquine | 0 | 84 |
| Total, serious adverse events | Chloroquine + Primaquine | 0 | 75 |
Source ClinicalTrials.gov
Papers2
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: Adequate Clinical and Parasitological Response (ACPR) | Trial comparisons |
| Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: Early Treatment Failure (ETF) | Trial comparisons |
| Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: Late Clinical Failure (LCF) | Trial comparisons |
| Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: Late Parasitological Failure (LPF) | Trial comparisons |
| Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: deaths from any cause | Trial comparisons |
| Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: serious adverse events | Trial comparisons |
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/NCT04222088
GET https://conductscience.org/api/trials/v1/NCT04222088/registered