AzTrials
AzTrials

Cutaneous LeishmaniasisPhase 2/3PCL01NCT00682656

Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

A Phase 2/3 study testing Glucantime® and Zithromax ® in people with Cutaneous Leishmaniasis, run by Ana Rabello at 3 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The adequate treatment of the American tegumentary leishmaniasis is crucial since the disease, differently from the caused by the Old World species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. Read more about this study

Who is it for?
Ages 14 to 65 years
Conditions the study is for
Cutaneous Leishmaniasis
What is being tested?
Glucantime® and Zithromax ®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
3 sitesBrazil
Study dates
Jun 2008to Sep 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients older than 14 and younger than 65 years old
  • Skin lesions with clinical suggestion of cutaneous leishmaniasis and positive leishmanin skin test(Montenegro test)or parasitological (direct observation of leishmania amastigotes, leishmania in vitro culture from aspirates, histopathological) and molecular(Polymerase Chain Reaction - PCR)samples.
  • No use of oral potentially antileishmanial drugs, or topics throughout the term of the current injury.
  • Absence of disseminated leishmaniasis.
  • Absence of mucosal involvement.
  • Agreement to participate in the study and signed the informed consent.

Who cannot join

  • Diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria.
  • Pregnancy
  • lactating mothers
  • Breast feeding
  • Cutaneous lesion with bacterial infection for which antibiotics need to be prescribed
  • More than six cutaneous lesions
Show all 10Show fewer
  • Previous history of cutaneous or mucosal leishmaniasis
  • Use of drugs with potential pharmacological interactions with antimonials as anti-arrhythmic or tricycle anti-depressives
  • Previous intolerance to azithromycin or other macrolides or N-methylglucamine
  • Abusive alcohol ingestion according to the CAGE questionnaire

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

  • Centro de Pesquisas René Rachou - Fiocruz

    Belo Horizonte, Minas Gerais, 30190-002

  • University Estadual de Montes Claros

    Montes Claros, Minas Gerais, 39401-002

  • Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras

    Presidente Tancredo Neves, Estado de Bahia, 45416-000

Other trials in Brazil

About this study

Official title: Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis

The adequate treatment of the American tegumentary leishmaniasis is crucial since the disease, differently from the caused by the Old World species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis (CL), however, these drugs present high frequency of side effects and important disadvantages as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin is a macrolide antibiotic, non-expensive, largely commercially available that has shown in-vitro and in vivo activity against different species of Leishmania.

The main objective of this study is to evaluate the efficacy and safety of oral azithromycin for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20 days is going to be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow up lasts for 12 months.

Read the detailed description

Included a new site (University Estadual de Montes Claros - UNIMONTES) in 7 June 2010. The site was included due the need to achieve more patients. The ANVISA (National Agency of Sanitary Surveillance) approved these site in March 2011 and the start of activities is planned for June 2011.

Being tested
Glucantime®, Zithromax ®
Keywords
cutaneous leishmaniasis, azithromycin, N- methyl glucamine
Medical subject headings
Leishmaniasis, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucantime®Drug

    Also called meglumine antimoniate

    15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day

  • Zithromax ®Drug

    Also called SELIMAX®

    Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days

Study groups in NCT00682656
Study groupRoleWhat they receive
A - N- methyl glucamineActive comparatorGlucantime® , max day of 1,215 mg
Receives: Drug: Glucantime®
B - AzithromycinExperimentalZithromax ® , one dose 500 mg
Receives: Drug: Zithromax ®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of clinically cured patients

    A cure was defined as complete lesion healing and re-epithelialization without inflammatory infiltration and erythema until 90 days after the treatment ended.

    Measured: at the third month after treatment

Secondary outcomes (4)

  1. Proportion of patients with failure and cured

    Proportion of cured patients at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment. Mean time to healing.

    Measured: twelve months after treatment

  2. Occurrence of mucosal lesions after treatment

    Proportion of patients with relapsed or mucosal lesion in 6 months, 9 and 12 follow-up after completion of treatment.

    Measured: twelve months after treatment

  3. Proportion of patients presenting new lesions

    Proportion of patients with new lesions at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment.

    Measured: 1st 2nd 3rd 6th 12th month after treatment

  4. Proportion of adverse events on each treatment group

    Proportion of patients clinical, electrocardiographic and laboratory adverse events.

    Measured: 1st 2nd 3rd 6th 12th month after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2011
  4. Study completionSep 2012

Why it stopped: Efficacy issues on test arm

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00682656
Sponsor's protocol ID
CEPSH/CPqRR 21/2006
Acronym
PCL01
Status last verified
Jul 2011
First submitted
20 May 2008
Last updated
17 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Glucantime® and Zithromax ® in people with Cutaneous Leishmaniasis, run by Ana Rabello at 3 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Efficacy issues on test arm). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of clinically cured patients (time frame: at the third month after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00682656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in