Trial · NCT03660839
Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
NCT03660839, Phase 2, Completed, Sanofi; results first posted 2020-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria. Trials, record NCT03660839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03660839
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
- NCT number
- NCT03660839
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Plasmodium Falciparum Infection
- Interventions
- Artefenomel (OZ439), Ferroquine (SSR97193)
- First posted
- 2018-09-07
- Last updated
- 2022-03-21
- Results first posted
- 2020-12-02
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | Day 28 | ACPR:absence of parasitemia at Day 28, irrespective of axillary temperature(AT), participants not meeting any criteria of early therapy failure(ETF):Danger signs(DS)/symptoms of complicated(SoC)/severe malaria(SM) at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia;or parasitemia on Day 2 \>Day 0 irrespective of AT;or parasitemia on Day 3 with AT\>=37.5 degree Celsius (°C);or parasitemia count on Day 3 \>=25 percent (%) on Day 0, or late clinical failure (LCF):DS/SM in presence of parasitemia between Day 4 and 28,concomitant to at least one positive parasitemia;or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or late parasitological failure(LPF):presence of parasitemia between Day 7 and 28 and AT\<37.5°C and without rescue therapy. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with reinfection. |
| Secondary | Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | Day 28 | ACPR: absence of parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS/SoC/SM at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia; or parasitemia on Day 2 \> Day 0 irrespective of AT; or parasitemia on Day 3 with AT \>=37.5°C; or parasitemia count on Day 3 \>=25% on Day 0, or LCF: DS/SM in presence of parasitemia between Day 4 and 28, concomitant to at least one positive parasitemia; or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or LPF: presence of parasitemia between Day 7 and 28 and AT\<37.5°C or having rescue therapy for malaria. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish reinfection (new clone of parasite) or recrudescence. |
| Secondary | Parasitemia: Change From Baseline in Number of Parasites Per Microliter of Blood at 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 Hours | Baseline, 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 hours post-dose | Parasitemia (quantitative content of parasites present in the blood) at baseline until Day 7 (i.e. 168 hours) was assessed by optical microscope. |
| Secondary | Observed Parasite Reduction Ratio (PRR) at 24 Hours, 48 Hours, and 72 Hours | Baseline, 24, 48 and 72 hours post-dose | The observed PRR was defined as the ratio of the number of parasites at time t=0 (baseline) divided by the parasite count at each specified time t (post-treatment). If the post dose parasite count = 0 (due to a negative parasitemia) then a value of 1 parasite per microliter was imputed to allow a parasite reduction ratio calculation. |
| Secondary | Time to 50% and 99% Parasite Reduction | Up to Day 28 | Time to 50% and 99% parasite reduction was defined as time needed for the parasitemia (quantitative content of parasites present in blood) to be reduced to 50% and 99% of the initial value, respectively. |
| Secondary | Parasite Clearance Time (PCT) | From the start of study drug administration up to the time of the first negative blood film (up to Day 28) | PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites by microscopy). This first negative film was confirmed by a second negative film which was taken \>=6 to \<=12 hours of the first film. If the second film was performed \<6 hours or \>12 hours of the first film, then the parasite clearance was confirmed or invalidated by the third (thick) film following the second one, whatever the timing of this third film: If the third film was negative, then the clearance was considered confirmed and if the third film was positive, then the clearance was invalidated. Kaplan-Meier method was used for the estimation. |
| Secondary | Parasite Clearance Rate | Up to Day 28 | Parasite clearance rate (k) is the minus slope of the natural logarithm parasitemia versus time linear relationship, after exclusion of outliers, lag phase and Tail, using the worldwide antimalarial resistance network, Parasite Clearance Estimator. |
| Secondary | Time to Re-emergence | Up to Day 28 | Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Re-emergence was confirmed by microscopy (positive blood smear). Participants with confirmed parasite clearance were included in the analysis and Kaplan-Meier method was used for estimation. |
| Secondary | Time to Recrudescence | Up to Day 28 | Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Participants with confirmed parasite clearance were included in the analysis and Kaplan-Meier method was used for estimation. |
| Secondary | Time to Re-infection | Up to Day 28 | Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differed from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Participants with confirmed parasite clearance were involved in the analysis and Kaplan-Maier method was used for estimation. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | Day 28 | Pharmacokinetic/Pharmacodynamic (PK/PD) efficacy population: who received at least 1 dose of OZ439/FQ with parasitologically confirmed Plasmodium falciparum at baseline with data post-randomization, 1 evaluable PK blood sample (OZ439/FQ) post dose, adequate documentation of dosing \& sampling date, without any major protocol deviation related to drug administration (e.g. vomiting after drug intake). Here,overall number of participants analyzed=participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | Day 28 | Analysis was performed on PK/PD efficacy population. | percentage of participants | NUMBER |
| SECONDARY | Parasitemia: Change From Baseline in Number of Parasites Per Microliter of Blood at 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 Hours | Baseline, 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 hours post-dose | Analysis was performed on modified intention-to-treat (mITT) population which included all randomized participants with parasitological confirmed P.falciparum malaria at baseline with parasitemia data post-randomization, received the single administration of OZ439/FQ. Here, number analyzed = participants with available data for each specified category. | parasites per microliter | MEAN |
| SECONDARY | Observed Parasite Reduction Ratio (PRR) at 24 Hours, 48 Hours, and 72 Hours | Baseline, 24, 48 and 72 hours post-dose | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. | ratio | MEAN |
| SECONDARY | Time to 50% and 99% Parasite Reduction | Up to Day 28 | Analysis was performed on mITT population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | hours | MEAN |
| SECONDARY | Parasite Clearance Time (PCT) | From the start of study drug administration up to the time of the first negative blood film (up to Day 28) | Analysis was performed on mITT population. | hours | MEDIAN |
| SECONDARY | Parasite Clearance Rate | Up to Day 28 | Analysis was performed on mITT population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | 1 per hour | MEAN |
| SECONDARY | Time to Re-emergence | Up to Day 28 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Time to Recrudescence | Up to Day 28 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Time to Re-infection | Up to Day 28 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | days | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group278
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | Ferroquine 400 mg | 80.8 | 95% Confidence Interval 62.1 to 91.5 | percentage of participants | |
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | Ferroquine 400 mg + Artefenomel 300 mg | 90.3 | 95% Confidence Interval 75.1 to 96.7 | percentage of participants | |
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | Ferroquine 400 mg + Artefenomel 600 mg | 90.9 | 95% Confidence Interval 76.4 to 96.9 | percentage of participants | |
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | Ferroquine 400 mg + Artefenomel 1000 mg | 87.1 | 95% Confidence Interval 71.1 to 94.9 | percentage of participants | |
| Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | Ferroquine 400 mg | 64.5 | 95% Confidence Interval 46.9 to 78.9 | percentage of participants | |
| Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | Ferroquine 400 mg + Artefenomel 300 mg | 81.8 | 95% Confidence Interval 65.6 to 91.4 | percentage of participants | |
| Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | Ferroquine 400 mg + Artefenomel 600 mg | 77.8 | 95% Confidence Interval 61.9 to 88.3 | percentage of participants | |
| Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | Ferroquine 400 mg + Artefenomel 1000 mg | 78.1 | 95% Confidence Interval 61.2 to 89 | percentage of participants | |
| Parasitemia: Change From Baseline in Number of Parasites Per Microliter of Blood at 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 Hours | Ferroquine 400 mg | Baseline | 17496.0 | Standard Deviation 11889.55 | parasites per microliter |
| Parasitemia: Change From Baseline in Number of Parasites Per Microliter of Blood at 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 Hours | Ferroquine 400 mg + Artefenomel 300 mg | Baseline | 18799.6 | Standard Deviation 13559.14 | parasites per microliter |
1 to 10 of 278Source ClinicalTrials.gov
See all 278 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ferroquine (FQ) 400 Milligram (mg) | 35 | |
| Overall Study | STARTED | Ferroquine 400 mg + Artefenomel (OZ439) 300 mg | 36 | |
| Overall Study | STARTED | Ferroquine 400 mg + Artefenomel 600 mg | 36 | |
| Overall Study | STARTED | Ferroquine 400 mg + Artefenomel 1000 mg | 33 | |
| Overall Study | COMPLETED | Ferroquine (FQ) 400 Milligram (mg) | 35 | |
| Overall Study | COMPLETED | Ferroquine 400 mg + Artefenomel (OZ439) 300 mg | 36 | |
| Overall Study | COMPLETED | Ferroquine 400 mg + Artefenomel 600 mg | 36 | |
| Overall Study | COMPLETED | Ferroquine 400 mg + Artefenomel 1000 mg | 33 | |
| Overall Study | NOT COMPLETED | Ferroquine (FQ) 400 Milligram (mg) | 0 | |
| Overall Study | NOT COMPLETED | Ferroquine 400 mg + Artefenomel (OZ439) 300 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
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 | Anaemia | Blood and lymphatic system disorders | Ferroquine 400 mg | 0 | 35 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Ferroquine 400 mg + Artefenomel 300 mg | 2 | 36 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Ferroquine 400 mg + Artefenomel 600 mg | 1 | 36 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Ferroquine 400 mg + Artefenomel 1000 mg | 0 | 33 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ferroquine 400 mg | 2 | 35 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ferroquine 400 mg + Artefenomel 300 mg | 0 | 36 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ferroquine 400 mg + Artefenomel 600 mg | 0 | 36 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ferroquine 400 mg + Artefenomel 1000 mg | 0 | 33 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Ferroquine 400 mg | 1 | 35 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Ferroquine 400 mg + Artefenomel 300 mg | 4 | 36 | 4 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ferroquine 400 mg | 0 | 35 |
| Total, all-cause mortality | Ferroquine 400 mg + Artefenomel 300 mg | 0 | 36 |
| Total, all-cause mortality | Ferroquine 400 mg + Artefenomel 600 mg | 0 | 36 |
| Total, all-cause mortality | Ferroquine 400 mg + Artefenomel 1000 mg | 0 | 33 |
| Total, other adverse events | Ferroquine 400 mg | 13 | 35 |
| Total, other adverse events | Ferroquine 400 mg + Artefenomel 300 mg | 17 | 36 |
| Total, other adverse events | Ferroquine 400 mg + Artefenomel 600 mg | 17 | 36 |
| Total, other adverse events | Ferroquine 400 mg + Artefenomel 1000 mg | 22 | 33 |
| Total, serious adverse events | Ferroquine 400 mg | 0 | 35 |
| Total, serious adverse events | Ferroquine 400 mg + Artefenomel 300 mg | 0 | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36597076 | DERIVED |
Source PubMed
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.
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