Background
Methods
Study period and area
Study design and population
Inclusion criteria
Exclusion criteria
Patient enrolment, treatment and follow-up
Drug quality analysis
Parasite detection
Pregnancy test and haemoglobin determination
Quality assurance
Data analysis
Study variables and operational definition
Early treatment failure(ETF)
Late treatment failure(LTF)
Adequate response(AR)
Results
Baseline characteristics of the study participants
Variables | Total Number (%) |
---|---|
Gender | |
Male | 44(54.3) |
Female | 37(45.7) |
Age (in years) | |
Median | 19 |
Range | 1.6(18 months) - 42 |
Duration of illness before the day of enrollment | |
One day | 19(25.3) |
Two days | 46(55.4) |
Three days | 14(16.9) |
Four days | 2(2.4) |
Average mean body temperature on day 0 | 38.2 °C |
Average mean body temperature on day 28 | 36.8 °C |
Mean geometric parasite density on day 0 | 2270 parasites /μl |
Mean geometric parasite density on day 28 | 1390 /μl |
Parasite Reduction Ratio | 2.7/μl |
Efficacy outcomes
Anemia | Age in years (day 0) | Total | Age in years (day 28) | Total | ||||
---|---|---|---|---|---|---|---|---|
1–4 | 5–14 | > 15 | 1–4 | 5–14 | > 15 | |||
Non anemiaa | 3 | 9 | 35 | 47 | 0 | 2 | 79 | 79 |
Milda | 4 | 5 | 18 | 27 | 0 | 2 | 0 | 2 |
Moderatea | 3 | 2 | 2 | 7 | 0 | 0 | 0 | 0 |
Severa | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Follow up period | At Risk | Excluded from the study | Treatment failure | Survival Probability Estimate | Cumulative Hazard |
---|---|---|---|---|---|
Day 0 | 87 | 0 | 0 | 1 | 0 |
Day 1 | 87 | 0 | 0 | 1 | 0 |
Day 2 | 87 | 1 | 0 | 1 | 0 |
Day 3 | 86 | 0 | 0 | 1 | 0 |
Day 7 | 86 | 3 | 0 | 1 | 0 |
Day 14 | 83 | 2 | 0 | 1 | 0 |
Day 21 | 81 | 0 | 1 | 0.99 | 0.01 |
Day 28 | 79 | 0 | 1 | 0.96 | 0.04 |
Total | 6 | 2 |