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EFFICACY OF COMBINATION OF SYSTEMIC MEGLUMINE ANTIMONIATE AND CO-TRIMOXAZOLE VS MEGLUMINE ANTIMONIATE ALONE IN THE TREATMENT OF CUTANEOUS LEISHMANIASIS, A RANDOMIZED CONTROLLED TRIAL

EFFICACY OF COMBINATION OF SYSTEMIC MEGLUMINE ANTIMONIATE AND CO-TRIMOXAZOLE VS MEGLUMINE ANTIMONIATE ALONE IN THE TREATMENT OF CUTANEOUS LEISHMANIASIS, A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251014007
Enrollment
64
Registered
2025-10-14
Start date
2025-03-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cutaneous leishmaniasis cutaneous leishmaniasis meglumine antimoniate co-trimoxazole efficacy

Interventions

Participants were randomly allocated to two groups using a lottery method. Group A: receive I/M injection meglumine antimoniate (15 mg/kg/day) and oral co-trimoxazole. Patients will attend 2 weekly fo
Active Comparator Drug,Active Comparator Drug
meglumine antimoniate plus co-trimoxazole,meglumine antimoniate

Sponsors

COMBINED MILITARY HOSPITAL QUETTA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)Positive LD bodies and confirmation by H/P 2)Patients of both genders 3)Age between15-65 years 4)Multiple lesions on body 5)Lesions on lower legs, over a joint, mucosa or cartilage 6)Lesion(s) > 4 cm in size 7)Lesions not responding to local treatment 8)Lesions that are potentially disfiguring or disabling (i.e. on face, fingers or toes)

Exclusion criteria

Exclusion criteria: 1)Patients who are immunocompromised or with comorbidities (eg. DM, HTN, IHD) 2)People with a known hypersensitivity or allergy to meglumine antimoniate or co-trimoxazole. 3)Pregnant and breastfeeding women 4)Patients enrolled in other research protocol

Design outcomes

Primary

MeasureTime frame
clinical cure by week 12 12 weeks clinical response criteria

Secondary

MeasureTime frame
comparison of efficacy of both groups 12 weeks clinical response criteria

Countries

Pakistan

Contacts

Public Contactrabiya afzaal

COMBINED MILITARY HOSPITAL QUETTA

rabiyaafzaal@hotmail.com03344956996

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026