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Original TRDS for trail "Treatment for leishmaniasis" created on Oct 19, 2014


SLCTR Registration Number

SLCTR/2014/028

Date of Registration

18 Oct 2014

The date of last modification

Oct 19, 2014

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Application Summary

Scientific Title of Trial

Randomized, double blind, controlled study on efficacy and safety of intralesional metronidazole vs intralesional sodium stibogluconate in L. donovani cutaneous leishmaniasis

Public Title of Trial

Treatment for leishmaniasis

Disease or Health Condition(s) Studied

Cutaneous leishmaniasis

Scientific Acronym

None

Public Acronym

None

Brief title

Intralesional metronidazole in cutaneous leishmaniasis

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

None


Trial Details

What is the research question being addressed?

What is the efficacy and safety of intralesional metronidazole compared to intralesional sodium stibogluconate in L. donovani cutaneous leishmaniasis?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Standard therapy

Assignment

Parallel

Purpose

Treatment

Study Phase

Intervention(s) planned

Consenting participants meeting inclusion/exclusion criteria will be randomized into two arms.

Arm 1 (intervention arm) will receive intralesional metronidazole 0.2-4ml per lesion depending on the size of the lesion, weekly until cure or maximum of 10 (ten) injections

Arm 2 (control arm) will receive intralesional stibogluconate 0.2-4ml per lesion depending on the size of the lesion, weekly until cure or maximum of 10 (ten) injections

Inclusion criteria

  1. >12 years of age
  2. Positive slit skin smear and /or skin biopsy for leishmania parasites

Exclusion criteria

  1. Pregnancy
  2. Breast feeding
  3. Known renal impairment
  4. Known liver impairment
  5. Congestive cardiac failure

Primary outcome(s)

1.
  1. Rate of clinical cure
  2. Side effects to drugs – anticipated local side effects are pain, ulceration, scarring, post inflammatpry hyperpigmentation or depigmentation. (Systemic side effects are not anticipated as the drug is given intralesional)
 [
  1. At 12 weeks
  2. Weekly until end of the intralesional therapy, then every 3 months for a total of 12 months
]

Secondary outcome(s)

1.
  1. Recurrence rate
  2. Evidence of viceralization
 [

Every 3 months from clinical cure for a total of 12 months

]

Target number/sample size

150 (75 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2014-11-01

Anticipated end date

2015-11-01

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

Funding approved by FAIRMED Foundation- SLMA Research Grant in Neglected Tropical Diseases- 2014

Regulatory approvals


State of Ethics Review Approval

Status

Date of Approval

Approval number

Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Ranthilaka R. Ranawaka
Consultant Dermatologist
Base Hospital Homagama, Homagama
0112855200
0718186148

ranthilaka37@yahoo.com

Contact Person for Public Queries

Ranthilaka R. Ranawaka
Consultant Dermatologist
Base Hospital Homagama, Homagama
0112855200
0718186148

ranthilaka37@yahoo.com

Primary study sponsor/organization

Base Hospital Hambanthota

Base Hospital Hambanthota, Hambanthota
Phone (Office): 0472220261


Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results