Trial Outcomes & Findings for Validation of RealAmp Method for the Diagnosis of Malaria in Endemic Areas of Brazil (NCT NCT02371395)
NCT ID: NCT02371395
Last Updated: 2018-10-23
Results Overview
These are the results of the different tests used in the evaluation.
Recruitment status
COMPLETED
Target enrollment
1000 participants
Primary outcome timeframe
12 months
Results posted on
2018-10-23
Participant Flow
Participant milestones
| Measure |
Patients With Suspected Malaria (Fever)
This was a study of enrolling patients with fever or history of fever for malaria testing. A total of 1,000 samples were collected from patients in Cruzeiro do Sul, Acre state from January to June, 2015.
|
|---|---|
|
Overall Study
STARTED
|
1000
|
|
Overall Study
COMPLETED
|
1000
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Arm
n=1000 Participants
This was a study of enrolling patients with fever or history of fever for malaria testing. A total of 1,000 samples were collected from patients in Cruzeiro do Sul, Acre state from January to June, 2015.
|
|---|---|
|
Age, Continuous
|
29.5 years
n=1000 Participants
|
|
Sex: Female, Male
Female
|
551 Participants
n=1000 Participants
|
|
Sex: Female, Male
Male
|
449 Participants
n=1000 Participants
|
|
Region of Enrollment
Brazil
|
1000 Participants
n=1000 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Those were patients presenting with suspected malaria.
These are the results of the different tests used in the evaluation.
Outcome measures
| Measure |
Single Arm
n=1000 Participants
This was a study of enrolling patients with fever or history of fever for malaria testing. A total of 1,000 samples were collected from patients in Cruzeiro do Sul, Acre state from January to June, 2015.
|
|---|---|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by reference test · Mixed infection
|
20 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by local microscopy · P. falciparum
|
42 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by local microscopy · P. vivax
|
153 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by local microscopy · Mixed infection
|
0 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by local microscopy · Species unidentified
|
1 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by local microscopy · Negative
|
804 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by study microscopy · P. falciparum
|
56 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by study microscopy · P. vivax
|
169 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by study microscopy · Mixed infection
|
1 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by study microscopy · Species unidentified
|
0 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by study microscopy · Negative
|
774 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by RealAmp · P. falciparum
|
55 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by RealAmp · P. vivax
|
181 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by RealAmp · Mixed infection
|
0 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by RealAmp · Species unidentified
|
3 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by RealAmp · Negative
|
761 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by reference test · P. falciparum
|
48 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by reference test · P. vivax
|
152 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by reference test · Species unidentified
|
0 Participants
|
|
Malaria Diagnosis Using RealAmp and Microscopy.
Number of positive samples by reference test · Negative
|
780 Participants
|
Adverse Events
Single Arm
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