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Clinical trial with ivermectine for the treatment of Mansonella ozzardi infections

Clinical trial with ivermectine 150 mcg/kg for microfilarial clearance and observation of side-effects in the treatment of infections with Mansonella ozzardi

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000005257
Acronym
Mansonella Project Brazil
Enrollment
80
Registered
2009-01-06
Start date
2009-03-20
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

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

Interventions

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. P

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.

Sponsors

University of Sao Paulo
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to 60 Years
Healthy volunteers
No

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

Exclusion criteria

1-)Pregnant or breast-feeding women 2-)Less than 5 years old and older than 60 years

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026