Trial Outcomes & Findings for Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil (NCT NCT02600767)
NCT ID: NCT02600767
Last Updated: 2017-10-09
Results Overview
Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
28 days
Results posted on
2017-10-09
Participant Flow
Participant milestones
| Measure |
Artemether-Lumefantrine
Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.
Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil
Baseline characteristics by cohort
| Measure |
Artemether-Lumefantrine
n=79 Participants
Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.
Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.
|
|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysInvestigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.
Outcome measures
| Measure |
Artemether-Lumefantrine
n=74 Participants
Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.
Artemether-lumefantrine combination: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.
|
|---|---|
|
Absence of Malaria Parasites in Blood.
|
73 Participants
|
Adverse Events
Artemether-Lumefantrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place