Background
Methods
Trial design
Ethics
Participants
Location
Data capture system
Protocol of visits
Drugs for interventional therapy
Other drugs
Medical devices for interventional therapy
Randomization
Treatment protocols
Parasitological analyses and Leishmaniaspecies determination
Outcome
Sample size
Statistical analysis
Results
Enrolled patients
Recruitment
Baseline data
Per protocol (PP) evaluation | Test | |||||
---|---|---|---|---|---|---|
Group I | Group II | Group III | Total | p-value | ||
Male | 13 | 8 | 11 | 32 | Pearson Chi-Square | |
Female | 10 | 15 | 12 | 37 | 0.372* | Test (Exact-Sig.) |
Age (95% CI) | 26 (19-34) | 28 (22-33) | 33 (25-40) | 29 (25-33) | 0.308* | Kruskal-Wallis Test |
Lesion age (95% CI) | 9 (7-11) | 8 (7-10) | 7 (6-9) | 8 (7-9) | 0.437* | Kruskal-Wallis Test |
Lesion size (95% CI) | 3.7 (2.3-5.0) | 2.5 (1.7-3.3) | 3.0 (2.0-4.1) | 3.1 (2.5-3.7) | 0.421* | Kruskal-Wallis Test |
Parasite species
| ||||||
L. major | 4 | 5 | 7 | 16 | ||
L. tropica | 5 | 13 | 10 | 28 | Pearson Chi-Square | |
Not determined | 14 | 5 | 6 | 25 | 0.664* | Test (Exact-Sig.) |
Lesion location
| ||||||
Head | 5 | 3 | 2 | 10 | ||
Trunc | 0 | 0 | 1 | 1 | ||
Upper extr. | 12 | 16 | 14 | 42 | Pearson Chi-Square | |
Lower extr. | 6 | 4 | 6 | 16 | 0.666* | Test (Exact-Sig.) |
Parasite load according to Giemsa staining
| ||||||
Low (+) | 12 | 11 | 8 | 31 | ||
Moderate (++) | 8 | 12 | 14 | 34 | ||
High (+++) | 1 | 0 | 1 | 2 | Pearson Chi-Square | |
Not determined | 2 | 0 | 0 | 2 | 0.541* | Test (Exact-Sig.) |
Biopsy prior to treatment
| ||||||
Evaluable | 16 | 18 | 17 | 51 | Pearson Chi-Square | |
Not evaluable | 7 | 5 | 6 | 18 | 0.940* | Test (Exact-Sig.) |
Parasite load/g tissue (SEM) | 2.944 (1.645) × 106
| 3.081 (1.980) × 106
| 2.773 (1.785) × 106
| 2.935 (1.032) × 106
| 0.636* | Kruskal-Wallis Test |
Intention to treat (ITT) evaluation | Test | |||||
---|---|---|---|---|---|---|
Group I | Group II | Group III | Total | p-value | ||
Male | 14 | 12 | 15 | 41 | Pearson Chi-Square | |
Female | 10 | 17 | 13 | 40 | 0.446* | Test (Exact-Sig.) |
Age (95% CI) | 26 (19-33) | 28 (23-33) | 32 (25-38) | 29 (25-32) | 0.252* | Kruskal-Wallis Test |
Lesion age (95% CI) | 9 (7-10) | 9 (8-11) | 7 (6-8) | 8 (7-9) | 0.187* | Kruskal-Wallis Test |
Lesion size (95% CI) | 3.6 (2.3-4.9) | 2.3 (1.7-3.0) | 2.7 (1.8-3.6) | 2.8 (2.3-3.4) | 0.204* | Kruskal-Wallis Test |
Parasite species
| ||||||
L. major | 5 | 7 | 9 | 21 | ||
L. tropica | 5 | 14 | 11 | 30 | Pearson Chi-Square | |
Not determined | 14 | 8 | 8 | 30 | 0.614* | Test (Exact-Sig.) |
Lesion location
| ||||||
Head | 5 | 4 | 4 | 13 | ||
Trunc | 0 | 0 | 1 | 1 | ||
Upper extr. | 12 | 19 | 16 | 47 | Pearson Chi-Square | |
Lower extr. | 7 | 5 | 7 | 19 | 0.799* | Test (Exact-Sig.) |
Parasite load according to Giemsa staining
| ||||||
Low (+) | 13 | 16 | 11 | 40 | ||
Moderate (++) | 8 | 13 | 16 | 37 | ||
High (+++) | 1 | 0 | 1 | 2 | Pearson Chi-Square | |
Not determined | 2 | 0 | 0 | 2 | 0.534* | Test (Exact-Sig.) |
Biopsy prior to treatment
| ||||||
Evaluable | 17 | 23 | 22 | 62 | Pearson Chi-Square | |
Not evaluable | 7 | 6 | 6 | 19 | 0.800* | Test (Exact-Sig.) |
Parasite load/g tissue (SEM) | 2.773 (1.554)x106
| 3.430 (1.736)x106
| 2.368 (1.526)x106
| 2.889 (0.932)x106
| 0.691* | Kruskal-Wallis Test |
Primary outcome
Per protocol (PP) evaluation | |||||
---|---|---|---|---|---|
Group I | Group II | Group III | Total | p-value | |
< D75
| 15 | 23 | 20 | 58 | |
≥ D75
| 8 | 0 | 3 | 11 | 0.004* |
Unknown
| NA | NA | NA | NA | |
Total
| 23 | 23 | 23 | 69 |
Intention to treat (ITT) evaluation | |||||
---|---|---|---|---|---|
Group I | Group II | Group III | Total | p-value | |
< D75
| 15 | 23 | 20 | 58 | |
≥ D75
| 8 | 0 | 4 | 12 | |
Unknown
| 1 | 6 | 4 | 11 | 0.009* |
Total
| 24 | 29 | 28 | 81 |
Secondary outcome
Intention to treat (ITT) evaluation | ||||
---|---|---|---|---|
Group I | Group II | Group III | Overall | |
Mean (95% CI)
| 69 (50-90) | 35 (30-40) | 66 (41-91) | 58 (46-70) |
Median (95% CI)
| 63 (50-75) | 34 (29-39) | 51 (17-85) | 44 (32-56) |
Group I | Group II | Group III | |
---|---|---|---|
Group I
| 0.000001/0.000040 | 0.047032/0.507623 | |
Group II
| 0.000001/0.000040 | 0.022813/0.013589 | |
Group III
| 0.047032/0.507623 | 0.022813/0.013589 |
Per protocol (PP) evaluation | ||||
---|---|---|---|---|
Group I | Group II | Group III | Overall | |
Mean (95% CI)
| 69 (49-89) | 33 (29-37) | 45 (34-56) | 49 (41-57) |
Median (95% CI)
| 63 (47-79) | 32 (27-37) | 35 (21-49) | 37 (31-43) |