MansonelliasisNCT00215280
Epidemiology and Control of Mansonella Perstans Infection in Uganda
A study testing ivermectin and albendazole in people with Mansonelliasis and Pruritus, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mansonelliasis, Pruritus, Lymphoedema
- What is being tested?
- ivermectin and albendazole
- How many people
- 1,000 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2005to Feb 2006
- Phase
- Interventional
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals >= 5 years with or without M. perstans infection
Who cannot join
- Individuals < 5 years
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studies on the Epidemiology and Control of Mansonella Perstans Infection in Uganda
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.
Read the 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.
- Conditions
- Mansonelliasis, Pruritus, Lymphoedema, Abdominal Pains
- Being tested
- ivermectin and albendazole
- Keywords
- Mansonella perstans, microfilaraemia, ivermectin, albendazole, Uganda
- Medical subject headings
- Mansonelliasis, Pruritus, Lymphedema, Abdominal Pain, Dipetalonema Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivermectin and albendazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MansonelliasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Investigators
- Asanta M Asio, Msc, Principal investigator, Ministry of Health, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215280
- Sponsor's protocol ID
- MV917090205
- Status last verified
- Apr 2007
- First submitted
- 21 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
Publications
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.
PubMed 19081121Asio 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.
PubMed 18809192
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Epidemiology and Control of Mansonella Perstans Infection in Uganda
- ClinicalTrials.gov ID
- NCT00215280
- Acronym / sponsor ID
- MV917090205
- Conditions
- Mansonelliasis, Pruritus, Lymphoedema, Abdominal Pains
- Keywords
- Mansonella perstans, microfilaraemia, ivermectin, albendazole, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Study start
- Nov 2005
- Study completion
- Feb 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals >= 5 years with or without M. perstans infection
Key exclusion criteria (2 listed)
- Individuals < 5 years
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ivermectin and albendazole | Drug | – |
Primary outcome
microfilariae periodicity patterns
epidemiology of M. perstans at community level
clinical spectre among infected
reduction in microfilaraemia
1 secondary outcome
treatment effect on clinical manifestations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
- Derived from this study: PubMed 19081121Asio 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.
- Derived from this study: PubMed 18809192Asio 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.
- Related InfoLink provided by the sponsor.
Related trials for Mansonelliasis
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asanta M Asio, Msc principal investigator
Ministry of Health, Uganda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ivermectin and albendazole in people with Mansonelliasis and Pruritus, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
microfilariae periodicity patterns. The study lists 4 primary outcomes in all. 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 NCT00215280, which also lists 2 linked publications.
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 20 Apr 2007.