Loiasis With Positive Blood MicrofilaremiaLoPoMiNCT06194149
Assessment and Treatment of Loiasis With Positive Microfilaremia
An observational study of Loiasis With Positive Blood Microfilaremia, run by University Hospital, Angers.
Trial summary
Loiasis is a vector-borne filariasis endemic in the forested areas in Central Africa whose incidence and morbi-mortality are poorly understood. Estimated prevalence is around 10 millions cases for a population around 30 million people. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Loiasis With Positive Blood Microfilaremia
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 30 Jun 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Our cohort study is composed of patients diagnosed with loiasis with at least one positive blood microfilaremia > 0mf/ml. Patients are screened using data avalaible in the parasitology laboratories in our partcipating centers. Data are collected anonimously.
Who may be able to join
- Patient managed in one of the participating centers between the 01/01/2000 and the 12/31/2022
- Loiasis diagnosis with at least one positive blood microfilaremia > 0mf/ml
- Patient treated against loiasis
- At least one clinical and/or biological assessment after the first treatment dose
Who cannot join
- Patients not fulfilling inclusion criteria
About this study
Loiasis is a vector-borne filariasis endemic in the forested areas in Central Africa whose incidence and morbi-mortality are poorly understood. Estimated prevalence is around 10 millions cases for a population around 30 million people. Considered to be a benign pathology, it has recently been associated with excess mortality, mainly in cases with major microfilaremia (> 8000 mf/ml).
Transmission is related to a mostly diurnal vector from the Chrysops genus. Adult worms are located in skin and subcutaneous tissues of infected patients. Females worms produce microfilariae which join bloodstream. Infected patients are mainly asymptomatic. Nevertheless, adult worms migration can lead to transient oedema (" œdème de Calabar ") ; adult worm can also be observed during subcunjonctival migration. Hypereosinophilia is also frequently encountered. Microfilariae presence in the bloodstream is asymptomatic, even in individuals with major microfilaremia.
Read more
Treatment differs according to the initial microfilaremia. There are three drugs available : diethylcarbamazine (DEC) ; albendazole (ALB) and ivermectin (IVM) each with different macrofilaricidal and microfiliaricidal activities. Several treatment guidelines based on the initial microfilaremia and drug activities have been proposed, on the basis of limited data. DEC is suggested for patients with microfilaremia < 2000 mf/ml. Regarding patients with microfilaremia between 2000 and 8000 mf/ml, initial treatment with IVM followed by DEC is suggested. Regarding patients with microfilaremia between 8000 mf/ml and 30000 mf/ml, initial treatment with IVM or ALB followed by DEC is suggested. Regarding patients with microfilaremia > 30000 mf/ml, initial treatment with ALB or apheresis is suggested to reduce blood microfilaremia, followed by DEC. All these guidelines are associated with major adverse events, mainly life-threatening encephalopathies. These adverse events are mostly encountered in patients with major blood microfilaremia.
The objective is to describe clinical characteristics, the management and clinical and biological evolution of patients with loiasis and positive blood microfilaremia.
Read the detailed description
The protocol is based on the inclusion of patients diagnosed with loiasis with at least one positive blood microfilaremia > 0mf/ml between the 01/01/2000 and the 12/31/2022. Other inclusion criteria are specified below, including the necessity that patients were treated with a clinical and/or biological assessment after the first treatment.
Patients are screened using data available in the parasitology laboratories in tertiary centers in France (list of participating centers in progress). Data are collected in an anonymous way without identifying informations not requiring patients individual information. A local investigator at each center will collect the data then forward it to the main investigator. No correspondence list will be kept.
The primary outcome is focused on clinical and biological evolution after treatment for patients with loiasis and positive blood microfilaremia. Secondary outcomes are focused on the description of adverse events, description of initial clinical and biological characteristics and the description of therapeutic management. All outcomes are specified below.
Collected data are as follows :
- Initial data : demographic data (age at diagnosis, gender, country of origin, endemic country visited, length of stay, underlying conditions (HIV, hypertension, renal failure, immunosuppressive therapy, neoplasia)) / clinical data (current or previous symptoms possibly related to loasis: subcunjunctival migration, calabar swelling, pruritus, arthralgias, other types of manifestations (splenic, headache), length of symptoms, time between onset of symptoms and travel to endemic country / biological data (blood microfilaremia, blood count data (hemoglobin, blood hypereosinophilia, leucocytes) prior to treatment, creatininemia, proteinuria).
- Treatment data : treatment used (IVM, ALB or DEC) with duration and dosage if available, number of courses, use of combinations or sequential treatments, outpatient or inpatient treatment.
- Adverse events data : presence and description of adverse events / in particular, adverse events expected with treatment used in loasis: neurological disorders, hepatic cytolysis, renal impairment / percentage of adverse events requiring treatment discontinuation
- Evolution data : clinical assessment (vital status at last visit, at 6 months after treatment and 1 year after treatment (proportion of patients alive, deceased, lost to follow-up); for deceased patients: cause of death ; clinical evolution at last visit, at 6 months after treatment and 1 year after treatment (proportion of patients with symptoms related to loiasis)) / Biological assessment (microbiological evolution at last visit, 6 months after treatment and 1 year after treatment (proportion of patients with persistent microfilaremia/negative microfilaremia; median microfilaremia; proportion of patients with eosinophilia ≥ 0.5 G/L/having eosinophilia < 0.5 G/L; median eosinophilia)).
For descriptive analysis, quantitative data will be expressed as median or mean when the distribution is normal, while qualitative data will be expressed as a percentage. For comparative analyses, a Student's t test or a Mann Whitney test in the case of a non-normal distribution will be used to analyze quantitative data. A Chi2 test or a Fischer test in the case of a non-normal distribution will be used to analyze qualitative data. Survival analysis will be studied using a Kaplan Maier method. Any difference with a P < 0.05 will be considered significant.
The study results will enable the investigators to better describe the prognosis of patients with loiasis and positive blood microfilaremia , which is crucial to offer them appropriate management.
- Keywords
- Loiasis, Microfilariae, epidemiology, treatment, complication
- Medical subject headings
- Loiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
Vital status
Measured: At six months after treatment ; one year after treatment
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
Reason of death for deceased patients / Clinical assessment
Measured: At six months after treatment ; one year after treatment
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
percentage of patients with symptoms related to loiasis/ Biological assessment
Measured: At six months after treatment ; one year after treatment
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
percentage of patients with persistent positive microfilaremia / median microfilaremia
Measured: At six months after treatment ; one year after treatment
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
percentage of patients with hypereosinophilia > 0,5 G/l ; median eosinophilia
Measured: At six months after treatment ; one year after treatment
Secondary outcomes (1)
Description of adverse events after treatment in patients with loiasis and positive blood microfilaremia
presence of adverse events and especially major adverse events (encephalopathy, acute kidney injury, hepatic cytolysis)
Measured: one year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion15 Feb 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Loiasis With Positive Blood MicrofilaremiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194149
- Sponsor's protocol ID
- 49RC23_0402
- Acronym
- LoPoMi
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chesnais CB, Takougang I, Paguele M, Pion SD, Boussinesq M. Excess mortality associated with loiasis: a retrospective population-based cohort study. Lancet Infect Dis. 2017 Jan;17(1):108-116. doi: 10.1016/S1473-3099(16)30405-4. Epub 2016 Oct 21.
PubMed 27777031Boussinesq M. Loiasis: new epidemiologic insights and proposed treatment strategy. J Travel Med. 2012 May-Jun;19(3):140-3. doi: 10.1111/j.1708-8305.2012.00605.x. No abstract available.
PubMed 22530819Veletzky L, Eberhardt KA, Hergeth J, Stelzl DR, Zoleko Manego R, Mombo-Ngoma G, Kreuzmair R, Burger G, Adegnika AA, Agnandji ST, Matsiegui PB, Boussinesq M, Mordmuller B, Ramharter M. Distinct loiasis infection states and associated clinical and hematological manifestations in patients from Gabon. PLoS Negl Trop Dis. 2022 Sep 19;16(9):e0010793. doi: 10.1371/journal.pntd.0010793. eCollection 2022 Sep.
PubMed 36121900Bouchaud O, Matheron S, Loarec A, Dupouy Camet J, Bouree P, Godineau N, Poilane I, Cailhol J, Caumes E. Imported loiasis in France: a retrospective analysis of 167 cases with comparison between sub-Saharan and non sub-Saharan African patients. BMC Infect Dis. 2020 Jan 20;20(1):63. doi: 10.1186/s12879-019-4740-6.
PubMed 31959110Gardon J, Gardon-Wendel N, Demanga-Ngangue, Kamgno J, Chippaux JP, Boussinesq M. Serious reactions after mass treatment of onchocerciasis with ivermectin in an area endemic for Loa loa infection. Lancet. 1997 Jul 5;350(9070):18-22. doi: 10.1016/S0140-6736(96)11094-1.
PubMed 9217715Garcia A, Abel L, Cot M, Ranque S, Richard P, Boussinesq M, Chippaux JP. Longitudinal survey of Loa loa filariasis in southern Cameroon: long-term stability and factors influencing individual microfilarial status. Am J Trop Med Hyg. 1995 Apr;52(4):370-5. doi: 10.4269/ajtmh.1995.52.370.
PubMed 7741181
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Treatment of Loiasis With Positive Microfilaremia
- ClinicalTrials.gov ID
- NCT06194149
- Acronym / sponsor ID
- LoPoMi / 49RC23_0402
- Keywords
- Loiasis, Microfilariae, epidemiology, treatment, complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Jan 2024 (actual)
- 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.
Loiasis is a vector-borne filariasis endemic in the forested areas in Central Africa whose incidence and morbi-mortality are poorly understood. Estimated prevalence is around 10 millions cases for a population around 30 million people. Considered to be a benign pathology, it has recently been associated with excess mortality, mainly in cases with major microfilaremia (> 8000 mf/ml).
Transmission is related to a mostly diurnal vector from the Chrysops genus. Adult worms are located in skin and subcutaneous tissues of infected patients. Females worms produce microfilariae which join bloodstream. Infected patients are mainly asymptomatic. Nevertheless, adult worms migration can lead to transient oedema (" œdème de Calabar ") ; adult worm can also be observed during subcunjonctival migration. Hypereosinophilia is also frequently encountered. Microfilariae presence in the bloodstream is asymptomatic, even in individuals with major microfilaremia.
Treatment differs according to the initial microfilaremia. There are three drugs available : diethylcarbamazine (DEC) ; albendazole (ALB) and ivermectin (IVM) each with different macrofilaricidal and microfiliaricidal activities. Several treatment guidelines based on the initial microfilaremia and drug activities have been proposed, on the basis of limited data. DEC is suggested for patients with microfilaremia < 2000 mf/ml. Regarding patients with microfilaremia between 2000 and 8000 mf/ml, initial treatment with IVM followed by DEC is suggested. Regarding patients with microfilaremia between 8000 mf/ml and 30000 mf/ml, initial treatment with IVM or ALB followed by DEC is suggested. Regarding patients with microfilaremia > 30000 mf/ml, initial treatment with ALB or apheresis is suggested to reduce blood microfilaremia, followed by DEC. All these guidelines are associated with major adverse events, mainly life-threatening encephalopathies. These adverse events are mostly encountered in patients with major blood microfilaremia.
The objective is to describe clinical characteristics, the management and clinical and biological evolution of patients with loiasis and positive blood microfilaremia.
Detailed description
The protocol is based on the inclusion of patients diagnosed with loiasis with at least one positive blood microfilaremia > 0mf/ml between the 01/01/2000 and the 12/31/2022. Other inclusion criteria are specified below, including the necessity that patients were treated with a clinical and/or biological assessment after the first treatment.
Patients are screened using data available in the parasitology laboratories in tertiary centers in France (list of participating centers in progress). Data are collected in an anonymous way without identifying informations not requiring patients individual information. A local investigator at each center will collect the data then forward it to the main investigator. No correspondence list will be kept.
The primary outcome is focused on clinical and biological evolution after treatment for patients with loiasis and positive blood microfilaremia. Secondary outcomes are focused on the description of adverse events, description of initial clinical and biological characteristics and the description of therapeutic management. All outcomes are specified below.
Collected data are as follows :
- Initial data : demographic data (age at diagnosis, gender, country of origin, endemic country visited, length of stay, underlying conditions (HIV, hypertension, renal failure, immunosuppressive therapy, neoplasia)) / clinical data (current or previous symptoms possibly related to loasis: subcunjunctival migration, calabar swelling, pruritus, arthralgias, other types of manifestations (splenic, headache), length of symptoms, time between onset of symptoms and travel to endemic country / biological data (blood microfilaremia, blood count data (hemoglobin, blood hypereosinophilia, leucocytes) prior to treatment, creatininemia, proteinuria).
- Treatment data : treatment used (IVM, ALB or DEC) with duration and dosage if available, number of courses, use of combinations or sequential treatments, outpatient or inpatient treatment.
- Adverse events data : presence and description of adverse events / in particular, adverse events expected with treatment used in loasis: neurological disorders, hepatic cytolysis, renal impairment / percentage of adverse events requiring treatment discontinuation
- Evolution data : clinical assessment (vital status at last visit, at 6 months after treatment and 1 year after treatment (proportion of patients alive, deceased, lost to follow-up); for deceased patients: cause of death ; clinical evolution at last visit, at 6 months after treatment and 1 year after treatment (proportion of patients with symptoms related to loiasis)) / Biological assessment (microbiological evolution at last visit, 6 months after treatment and 1 year after treatment (proportion of patients with persistent microfilaremia/negative microfilaremia; median microfilaremia; proportion of patients with eosinophilia ≥ 0.5 G/L/having eosinophilia < 0.5 G/L; median eosinophilia)).
For descriptive analysis, quantitative data will be expressed as median or mean when the distribution is normal, while qualitative data will be expressed as a percentage. For comparative analyses, a Student's t test or a Mann Whitney test in the case of a non-normal distribution will be used to analyze quantitative data. A Chi2 test or a Fischer test in the case of a non-normal distribution will be used to analyze qualitative data. Survival analysis will be studied using a Kaplan Maier method. Any difference with a P < 0.05 will be considered significant.
The study results will enable the investigators to better describe the prognosis of patients with loiasis and positive blood microfilaremia , which is crucial to offer them appropriate management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our cohort study is composed of patients diagnosed with loiasis with at least one positive blood microfilaremia > 0mf/ml. Patients are screened using data avalaible in the parasitology laboratories in our partcipating centers. Data are collected anonimously.
Key inclusion criteria (4 listed)
- Patient managed in one of the participating centers between the 01/01/2000 and the 12/31/2022
- Loiasis diagnosis with at least one positive blood microfilaremia > 0mf/ml
- Patient treated against loiasis
- At least one clinical and/or biological assessment after the first treatment dose
Key exclusion criteria (1 listed)
- Patients not fulfilling inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
Time frame: At six months after treatment ; one year after treatment
Vital status
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
Time frame: At six months after treatment ; one year after treatment
Reason of death for deceased patients / Clinical assessment
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
Time frame: At six months after treatment ; one year after treatment
percentage of patients with symptoms related to loiasis/ Biological assessment
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
Time frame: At six months after treatment ; one year after treatment
percentage of patients with persistent positive microfilaremia / median microfilaremia
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia
Time frame: At six months after treatment ; one year after treatment
percentage of patients with hypereosinophilia > 0,5 G/l ; median eosinophilia
1 secondary outcome
Description of adverse events after treatment in patients with loiasis and positive blood microfilaremia
Time frame: one year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 27777031Chesnais CB, Takougang I, Paguele M, Pion SD, Boussinesq M. Excess mortality associated with loiasis: a retrospective population-based cohort study. Lancet Infect Dis. 2017 Jan;17(1):108-116. doi: 10.1016/S1473-3099(16)30405-4. Epub 2016 Oct 21.
- Background: PubMed 22530819Boussinesq M. Loiasis: new epidemiologic insights and proposed treatment strategy. J Travel Med. 2012 May-Jun;19(3):140-3. doi: 10.1111/j.1708-8305.2012.00605.x. No abstract available.
- Background: PubMed 36121900Veletzky L, Eberhardt KA, Hergeth J, Stelzl DR, Zoleko Manego R, Mombo-Ngoma G, Kreuzmair R, Burger G, Adegnika AA, Agnandji ST, Matsiegui PB, Boussinesq M, Mordmuller B, Ramharter M. Distinct loiasis infection states and associated clinical and hematological manifestations in patients from Gabon. PLoS Negl Trop Dis. 2022 Sep 19;16(9):e0010793. doi: 10.1371/journal.pntd.0010793. eCollection 2022 Sep.
- Background: PubMed 31959110Bouchaud O, Matheron S, Loarec A, Dupouy Camet J, Bouree P, Godineau N, Poilane I, Cailhol J, Caumes E. Imported loiasis in France: a retrospective analysis of 167 cases with comparison between sub-Saharan and non sub-Saharan African patients. BMC Infect Dis. 2020 Jan 20;20(1):63. doi: 10.1186/s12879-019-4740-6.
- Background: PubMed 9217715Gardon J, Gardon-Wendel N, Demanga-Ngangue, Kamgno J, Chippaux JP, Boussinesq M. Serious reactions after mass treatment of onchocerciasis with ivermectin in an area endemic for Loa loa infection. Lancet. 1997 Jul 5;350(9070):18-22. doi: 10.1016/S0140-6736(96)11094-1.
- Background: PubMed 7741181Garcia A, Abel L, Cot M, Ranque S, Richard P, Boussinesq M, Chippaux JP. Longitudinal survey of Loa loa filariasis in southern Cameroon: long-term stability and factors influencing individual microfilarial status. Am J Trop Med Hyg. 1995 Apr;52(4):370-5. doi: 10.4269/ajtmh.1995.52.370.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Loiasis With Positive Blood Microfilaremia, run by University Hospital, Angers.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia (time frame: At six months after treatment ; one year after treatment). The study lists 5 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 NCT06194149, which also lists 6 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 8 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.