Condition category
Infections and Infestations
Date applied
05/04/2005
Date assigned
07/06/2005
Last edited
26/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Naozin

ORCID ID

Contact details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland
naozins@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A30468

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Dermal leishmaniasis

Intervention

Intervention group: Alum-ALM and BCG combined with sodium stibo-gluconate (SSG)
Control group: Sodium stibo-gluconate (SSG)

Intervention type

Drug

Phase

Phase I

Drug names

Aluminium hydroxide precipitated autoclaved Leishmania major (Alum-ALM) + Bacillus Calmette-Guerin (BCG) + sodium stibo-gluconate (SSG)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/10/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females 7 - 60 years
2. Skin rash of greater than six months duration following a history of successful treatment for Visceral Leishmaniasis (VL)
3. Absence of other skin conditions
4. Positive Direct Agglutination Rest (DAT) or rk39
5. Willing for hospitalisation at Khartoum for 90 days
6. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Pregnant or lactating women
2. Concurrent/chronic illness
3. Known allergy to vaccine components
4. Other allergies requiring steroids and Levamisole
5. Known immunological deficiency-including human immunodeficiency virus (HIV)
6. Concurrent participation in any other drug or vaccine trial
7. Known or planned vaccination within one month prior to study

Recruitment start date

07/10/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

Sudan

Trial participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes