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Trial registered on ANZCTR


Registration number
ACTRN12609000005257
Ethics application status
Approved
Date submitted
5/12/2008
Date registered
6/01/2009
Date last updated
7/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial with ivermectine for the treatment of Mansonella ozzardi infections
Scientific title
Clinical trial with ivermectine 150 mcg/kg for microfilarial clearance and observation of side-effects in the treatment of infections with Mansonella ozzardi
Universal Trial Number (UTN)
Trial acronym
Mansonella Project Brazil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mansoneliasis caused by Mansonella ozzardi 4072 0
Condition category
Condition code
Public Health 4278 4278 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ivermectin is a semisynthetic product from Streptomyces avermitilis. A potent macrocyclic lactone disaccharide antiparasitic agent to prevent and treat parasite infection in animals and in human beings. The compound has activity against internal and external parasites as arthropods, insects, filaroidea, platyhelmints and protozoa. The usual dosage for human use is 150 or 200 micrograms/kg as an unique dose, per orum.
Treatment of human beings > 4 and <61 years old with ivermectine 150 mcg/kg. Patients will recieve one unique dose at the beginning of the treatment.
Intervention code [1] 3888 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5256 0
Microfilaremia clearance 30 and 180 days post ivermectin treatment
Timepoint [1] 5256 0
3, 30, 60 and 180 days post ivermectine treatment
Secondary outcome [1] 8856 0
Side-effects caused by ivermectin
Timepoint [1] 8856 0
3 days post ivermectine treatment

Eligibility
Key inclusion criteria
1-)Mansonella ozzardi parasitaemia present on hemoscopy
2-)Older than 4 years and younger than 61 years
3-)Not pregnant or breast-feeding
4-) Volunteer
Minimum age
5 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-)Pregnant or breast-feeding women
2-)Less than 5 years old and older than 60 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be examined by hemoscopy (venopuncture) for the presence of Mansonella ozzardi in their blood. These subjects are riverine inhabitants of Purus River in the municipality of Labrea, Amazonas State, an area of high prevalence of mansoneliasis. Those who agree will be enrolled in the study , will be treated with ivermectine 150 mcg/kg (as already used for the treatment of with Onchocerca volvulus infections ) in an unique dose and followed-up for 180 days
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Biochemistry blood test will be undertaken in days 0 and 3 in order to investigate hepatic, blood and renal injuries post ivermectin use
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1429 0
Brazil
State/province [1] 1429 0
Rondonia

Funding & Sponsors
Funding source category [1] 4346 0
Government body
Name [1] 4346 0
Ministry Of Health - Brazilian Government
Country [1] 4346 0
Brazil
Primary sponsor type
University
Name
University of Sao Paulo
Address
Rua Francisco Prestes , 1234
Monte Negro-Rondonia-Brazil
CEP 76.888-000
Country
Brazil
Secondary sponsor category [1] 3915 0
Government body
Name [1] 3915 0
Ministry Of Health - Brazilian Government
Address [1] 3915 0
Esplanada Dos Minist?rios
Bloco "G" Sala 222
DF-Bras?lia CEP 70.058-900
Country [1] 3915 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6403 0
Sao Lucas Human Ethic Comitee
Ethics committee address [1] 6403 0
Rua Alexandre Guimaraes, 1930
Porto Velho-Rondonia-BrazilCEP 78.900-000
Ethics committee country [1] 6403 0
Brazil
Date submitted for ethics approval [1] 6403 0
28/11/2008
Approval date [1] 6403 0
18/03/2009
Ethics approval number [1] 6403 0
324/2008

Summary
Brief summary
Mansonella ozzardi infection is highly prevalent in the Amazonian riverine population in Brazil. The Brazilian government has no drug protocol for the treatment of such disease. In order to determine the efficacy and safety of the use of ivermectine in the treatment of such disease, 50 subjects between 5-60 years old will be enrolled and treated with ivermectine 150 mcg/kg (the usual dosage for the treatment of Onchocerca volvulus infections) in an unique dose and followed-up for 180 days in order to observe microfilaremia clearance and the occurence of side-effects post ivermectin treatment
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29200 0
Address 29200 0
Country 29200 0
Phone 29200 0
Fax 29200 0
Email 29200 0
Contact person for public queries
Name 12357 0
Luis Marcelo Aranha Camargo
Address 12357 0
Rua Francisco Prestes , 1234
Monte Negro-Rondonia-Brazil
CEP 76.888-000
Country 12357 0
Brazil
Phone 12357 0
+5569-92198714
Fax 12357 0
+5569-35302053
Email 12357 0
[email protected]
Contact person for scientific queries
Name 3285 0
Luis Marcelo Aranha Camargo
Address 3285 0
Rua Francisco Prestes , 1234
Monte Negro-Rondonia-Brazil
CEP 76.888-000
Country 3285 0
Brazil
Phone 3285 0
+5569-92198714
Fax 3285 0
+5569-35302053
Email 3285 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.