Trial · NCT02083380
Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.
NCT02083380, Phase 2, Phase 3, Completed, Medicines for Malaria Venture; results first posted 2017-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria. Trials, record NCT02083380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02083380
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.
- NCT number
- NCT02083380
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 448 participants, actual
- Lead sponsor
- Medicines for Malaria Venture
- Conditions
- Uncomplicated Plasmodium Falciparum Malaria
- Interventions
- Artefenomel 800mg: piperaquine 640mg, Artefenomel 800mg: piperaquine 960mg, Artefenomel 800mg: piperaquine 1440mg
- First posted
- 2014-03-11
- Last updated
- 2017-03-10
- Results first posted
- 2017-01-30
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) | Day 28 | Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP). 95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Secondary | PCR - Adjusted ACPR at Day 42 in the PP Population | Days 42 | PCR - adjusted adequate clinical and parasitological response at Day 42 |
| Secondary | PCR-adjusted ACPR at Day 63 in the PP Population | Day 63 | PCR-adjusted adequate clinical and parasitological response at Day 63 |
| Secondary | Crude ACPR at Day 28 in the PP Population | Day 28 | Crude adequate clinical and parasitological response at Day 28 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| PRIMARY | PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages) | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| PRIMARY | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages) | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| PRIMARY | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years) | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| PRIMARY | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years) | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| PRIMARY | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years) | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| PRIMARY | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years) | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| SECONDARY | PCR - Adjusted ACPR at Day 42 in the PP Population | Days 42 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| SECONDARY | PCR-adjusted ACPR at Day 63 in the PP Population | Day 63 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. | % ACPR PCR-adjusted | NUMBER |
| SECONDARY | Crude ACPR at Day 28 in the PP Population | Day 28 | Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population. | % ACPR unadjusted (crude) | NUMBER |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) | A) Artefenomel 800mg: Piperaquine 640mg | 70.8 | 95% Confidence Interval 61.13 to 79.19 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) | B) Artefenomel 800mg: Piperaquine 960mg | 68.4 | 95% Confidence Interval 59.13 to 76.66 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) | C) Artefenomel 800mg: Piperaquine 1440mg | 78.6 | 95% Confidence Interval 70.09 to 85.67 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages) | A) Artefenomel 800mg: Piperaquine 640mg | 64 | 95% Confidence Interval 42.52 to 82.03 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages) | B) Artefenomel 800mg: Piperaquine 960mg | 64 | 95% Confidence Interval 42.52 to 82.03 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages) | C) Artefenomel 800mg: Piperaquine 1440mg | 70.4 | 95% Confidence Interval 49.82 to 86.25 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages) | A) Artefenomel 800mg: Piperaquine 640mg | 72.8 | 95% Confidence Interval 61.81 to 82.13 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages) | B) Artefenomel 800mg: Piperaquine 960mg | 69.6 | 95% Confidence Interval 59.10 to 78.73 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages) | C) Artefenomel 800mg: Piperaquine 1440mg | 81.1 | 95% Confidence Interval 71.49 to 88.59 | % ACPR PCR-adjusted | |
| PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years) | A) Artefenomel 800mg: Piperaquine 640mg | 77.8 | 95% Confidence Interval 52.36 to 93.59 | % ACPR PCR-adjusted |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A) Artefenomel 800mg: Piperaquine 640mg | 148 | |
| Overall Study | STARTED | B) Artefenomel 800mg: Piperaquine 960mg | 151 | |
| Overall Study | STARTED | C) Artefenomel 800mg: Piperaquine 1440mg | 149 | |
| Overall Study | COMPLETED | A) Artefenomel 800mg: Piperaquine 640mg | 57 | |
| Overall Study | COMPLETED | B) Artefenomel 800mg: Piperaquine 960mg | 56 | |
| Overall Study | COMPLETED | C) Artefenomel 800mg: Piperaquine 1440mg | 65 | |
| Overall Study | NOT COMPLETED | A) Artefenomel 800mg: Piperaquine 640mg | 91 | |
| Overall Study | NOT COMPLETED | B) Artefenomel 800mg: Piperaquine 960mg | 95 | |
| Overall Study | NOT COMPLETED | C) Artefenomel 800mg: Piperaquine 1440mg | 84 |
Source ClinicalTrials.gov
Adverse events45
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | malaria | Infections and infestations | A) Artefenomel 800mg: PQP 640mg | 34 | 146 | 34 |
| other | malaria | Infections and infestations | B) Artefenomel 800mg: PQP 960mg | 45 | 148 | 48 |
| other | malaria | Infections and infestations | C) Artefenomel 800mg: PQP 1440mg | 43 | 143 | 44 |
| other | Bronchitis | Infections and infestations | A) Artefenomel 800mg: PQP 640mg | 10 | 146 | 11 |
| other | Bronchitis | Infections and infestations | B) Artefenomel 800mg: PQP 960mg | 13 | 148 | 19 |
| other | Bronchitis | Infections and infestations | C) Artefenomel 800mg: PQP 1440mg | 13 | 143 | 16 |
| other | Rhinitis | Infections and infestations | A) Artefenomel 800mg: PQP 640mg | 10 | 146 | 10 |
| other | Rhinitis | Infections and infestations | B) Artefenomel 800mg: PQP 960mg | 9 | 148 | 10 |
| other | Rhinitis | Infections and infestations | C) Artefenomel 800mg: PQP 1440mg | 11 | 143 | 11 |
| other | Plasmodium Falciparum Infection | Infections and infestations | A) Artefenomel 800mg: PQP 640mg | 7 | 146 | 7 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A) Artefenomel 800mg: PQP 640mg | ||
| Total, all-cause mortality | B) Artefenomel 800mg: PQP 960mg | ||
| Total, all-cause mortality | C) Artefenomel 800mg: PQP 1440mg | ||
| Total, other adverse events | A) Artefenomel 800mg: PQP 640mg | 122 | 146 |
| Total, other adverse events | B) Artefenomel 800mg: PQP 960mg | 127 | 148 |
| Total, other adverse events | C) Artefenomel 800mg: PQP 1440mg | 115 | 143 |
| Total, serious adverse events | A) Artefenomel 800mg: PQP 640mg | 1 | 146 |
| Total, serious adverse events | B) Artefenomel 800mg: PQP 960mg | 1 | 148 |
| Total, serious adverse events | C) Artefenomel 800mg: PQP 1440mg | 2 | 143 |
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 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/NCT02083380
GET https://conductscience.org/api/trials/v1/NCT02083380/registered?page=2