NCT00215280

Brief Summary

Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the epidemiology of this infection, and of the morbidity it induces is poor, and no effective treatment is available. The study aims at providing data on diagnostic, epidemiological, morbidity and treatment aspects of M. perstans infections in Uganda.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

September 21, 2005

Last Update Submit

April 19, 2007

Conditions

MansonelliasisPruritusLymphoedemaAbdominal Pains

Keywords

Mansonella perstansmicrofilaraemiaivermectinalbendazoleUganda

Outcome Measures

Primary Outcomes (4)

  • microfilariae periodicity patterns

  • epidemiology of M. perstans at community level

  • clinical spectre among infected

  • reduction in microfilaraemia

Secondary Outcomes (1)

  • treatment effect on clinical manifestations

Interventions

ivermectin and albendazoleDRUG

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals \>= 5 years with or without M. perstans infection

You may not qualify if:

  • Individuals \< 5 years
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luwero

Luwero and Mukono, Luwero and Mukono Districts, Uganda

Location

Related Publications (2)

  • Asio SM, Simonsen PE, Onapa AW. A randomised, double-blind field trial of ivermectin alone and in combination with albendazole for the treatment of Mansonella perstans infections in Uganda. Trans R Soc Trop Med Hyg. 2009 Mar;103(3):274-9. doi: 10.1016/j.trstmh.2008.10.038. Epub 2008 Dec 9.

    PMID: 19081121DERIVED

  • Asio SM, Simonsen PE, Onapa AW. Mansonella perstans filariasis in Uganda: patterns of microfilaraemia and clinical manifestations in two endemic communities. Trans R Soc Trop Med Hyg. 2009 Mar;103(3):266-73. doi: 10.1016/j.trstmh.2008.08.007. Epub 2008 Sep 21.

    PMID: 18809192DERIVED

Related Links

MeSH Terms

Conditions

MansonelliasisPruritusLymphedemaAbdominal PainDipetalonema Infections

Interventions

IvermectinAlbendazole

Condition Hierarchy (Ancestors)

FilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLymphatic DiseasesHemic and Lymphatic DiseasesPainNeurologic ManifestationsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Asanta M Asio, Msc

    Ministry of Health, Uganda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 22, 2005

Study Start

November 1, 2005

Study Completion

February 1, 2006

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

UG(1)