Table 2. Description of patients and outcomes of treatment in the included studies.
Reference (Author) |
Enrolled participants (n) | Enrolled children n (%) | Age of enrolled children (years old; range*) | Leishmania species (%) | Definition of cure | Cure in children ITT n/N (%) |
Cure in adults ITT n/N (%) |
Cure in children PP n/N (%) |
Cure in adults PP n/N (%) |
---|---|---|---|---|---|---|---|---|---|
ACL | |||||||||
Castro MdM, et al.[5] | 60 | 30 (50) | 2–12 |
L.(V) panamensis (66.7); L.(V) braziliensis (3.3); Not isolated (30). |
Complete re-epithelialization and absence of inflammatory signs for all lesions at day 210. |
Miltefosine:
24/30 (80) |
Miltefosine:
28/30 (93.3) |
Miltefosine:
24/29 (82.7) |
Miltefosine:
28/28 (100) |
Chrusciak-T A, et al.[23] | 90 | 30 (33.3) | 4–12 |
L.(V) guyanensis (93.3); L.(V) braziliensis (3.3); L.(V) lainsoni (3.3). |
Complete epithelialization of all ulcers and complete disappearance of inflammatory induration from all lesions at 6 months follow-up visit. | No data | No data |
Miltefosine:
12/19 (63.1) Meglumine antimoniate: 5/9 (55.5). |
Miltefosine:
28/37 (75.7) Meglumine antimoniate: 10/19 (52.6) |
Machado P, et al.[24] | 90 | 32 (35.5) | 4–12 | L.(V) braziliensis (45.5). | Lesions with complete re-epithelialization, without raised borders, infiltrations or crusts at 6 months after the end of therapy. |
Miltefosine: 15/22 (68.2) Meglumine antimoniate: 7/10 (70) |
Miltefosine: 30/38 (78.9) Meglumine antimoniate: 9/20 (45). |
No data | No data |
Palacios R, et al.[7] | 136 | 86 (63.2) | ≤14** |
L.(V) panamensis (95.5); L.(V) braziliensis (4.5) † |
Initial clinical response (complete re-epithelialization and absence of inflammatory signs of all lesions at 13 weeks after initiation of treatment) and no relapses of lesions between 13 and 52 weeks of follow-up. |
Meglumine antimoniate 10 days: 0–4 y/o: (17) 5–14 y/o: (53) 20 days: 0–4 y/o: (24) 5–14 y/o: (68) |
Meglumine antimoniate 10 days: ≥15 y/o: (61) 20 days: ≥15 y/o: (69) |
Meglumine Antimoniate 10 days: 0–4 y/o: 1/9 (11) 5–14 y/o: 14/21 (67) 20 days: 0–4 y/o: 2/8 (25) 5–14 y/o: 12/16 (75) |
Meglumine Antimoniate 10 days: >14 y/o: 13/16 (81) 20 days: >14 y/o: 10/12 (83) |
Rubiano LC, et al.[22] | 116 | 116 (100) | 2–12 |
L.(V) panamensis (71.7); L.(V) guyanensis (26.6); L. (V) braziliensis (1.7) |
Initial clinical therapeutic response (complete re-epithelialization and absence of inflammatory signs of all lesions) attained by week 13 and maintained until week 26 without the appearance of new lesions. |
Miltefosine: 48/58 (82.8) a Meglumine antimoniate: 40/58 (69) a |
Not applicable |
Miltefosine: 48/55 (87.3) a Meglumine antimoniate: 40/56 (71.4) a |
Not applicable |
OWCL | |||||||||
Jaffar H. [25] | 62 | 32 (51.6) | 3–11 | Not reported. Author describes L.(L) tropica. and L.(L) major as endemic species in the region. |
Complete healing of lesions at the end of three months. | No data | No data |
Rifampicin:
15/18 (83.4) Placebo: 2/3 (66.6). |
Rifampicin:
6/16 (37.5) Placebo: 1/4 (25). |
Layegh P, et al. 2009[26] | 79 | 79 (100) |
Cryotherapy:
6.8 (3.4) *** Intralesional MA: 6.2(3.4) *** |
Not reported. Authors describe L.(L) tropica as endemic specie in the region. |
Full re-epithelialization of lesions; disappearance of edema, induration, and other signs of inflammation; and a negative direct skin smear result at six months after treatment. |
Cryotherapy: 15/40 (37.5) a Intralesional meglumine antimoniate: 26/39 (66.7) a |
Not applicable |
Cryotherapy:
15/36 (41.7) a Intralesional meglumine antimoniate: 26/36 (72.3) a |
Not applicable |
Layegh P, et al. 2011[27] | 112 | 56 (50) | ≤15** | Not reported. Authors describe L.(L) tropica as endemic species in the region. |
Full re-epithelialization of ulcers and 100% decrease of induration size for papulo-plaque or nodular lesions, at 45 days after treatment. |
Meglumine antimoniate:
18/56 (32.1) a |
Meglumine antimoniate:
31/56 (55.4) a |
Meglumine antimoniate: 18/51 (35.3) a |
Meglumine antimoniate: 31/49 (63.3) a |
* Data presented as range, unless other measure is specified
** No lower age limit was reported
*** Mean (SD)
† Data available for 88 of 136 patients; y/o: years old
a Proportion of cure was calculated by the reviewers, as authors reported treatment failure in the original manuscript.