Epidemiology and Control of Mansonella Perstans Infection... | NCT00215280

Studies
Epidemiology and Control of Mansonella Perstans Infection in Uganda

NCT00215280

Sponsor

DBL -Institute for Health Research and Development

Status

Completed

Last Update Posted

Apr 20, 2007Estimated

Enrollment

1,000

Phase

Not Applicable

Conditions

Mansonelliasis
Pruritus
Lymphoedema
Abdominal Pains

Interventions

ivermectin and albendazole

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2007

Last Update Posted Date

Apr 20, 2007Estimated

Name	Class
Ministry of Health, Uganda	OTHER_GOV

Description Module

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.

Detailed Description

Overall objective: to investigate diagnostic, epidemiological and treatment aspects of M. perstans in Uganda with relevance to control

Specific objectives:

To establish the pattern of diurnal periodicity of M. perstans microfilaraemia in humans
To establish the patterns of M. perstans microfilaraemia and possible clinical manifestations related to this infection in two communities with medium to high endemicity
To determine the efficacy of ivermectin alone and the combination of ivermectin and albendazole on M. perstans microfilaraemia.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000

Name	Type	Description	Arm Group Labels	Other Names
ivermectin and albendazole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microfilariae periodicity patterns
epidemiology of M. perstans at community level
clinical spectre among infected
reduction in microfilaraemia

Secondary Outcomes

Measure	Description	Time Frame
treatment effect on clinical manifestations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Individuals < 5 years
Pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asanta M Asio, Msc	Ministry of Health, Uganda	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Luwero		Luwero and Mukono	Luwero and Mukono Districts		Uganda

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19081121	Derived	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.
18809192	Derived

ID	Term
D008368	Mansonelliasis
D011537	Pruritus
D008209	Lymphedema
D015746	Abdominal Pain
D004154	Dipetalonema Infections

ID	Term
D005368	Filariasis
D017205	Spirurida Infections
D017190	Secernentea Infections
D009349	Nematode Infections

ID	Term
D007559	Ivermectin
D015766	Albendazole

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals