CClinicalTrials.gg
Not yet recruitingNCT06194149LoPoMiUpdated Jan 8, 2024

Assessment and Treatment of Loiasis With Positive Microfilaremia

An observational study in Loiasis With Positive Blood Microfilaremia, sponsored by University Hospital, Angers. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-01-08.

Sponsored by University Hospital, Angers · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Loiasis With Positive Blood Microfilaremia

Keywords

  • Loiasis
  • Microfilariae
  • epidemiology
  • treatment
  • complication
03

In context

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients not fulfilling inclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia

    Vital status

    Time frame: At six months after treatment ; one year after treatment

  2. Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia

    Reason of death for deceased patients / Clinical assessment

    Time frame: At six months after treatment ; one year after treatment

  3. 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

    Time frame: At six months after treatment ; one year after treatment

  4. Description of clinical and biological evolution of treated patients with loiasis and positive blood microfilaremia

    percentage of patients with persistent positive microfilaremia / median microfilaremia

    Time frame: At six months after treatment ; one year after treatment

  5. 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

    Time frame: 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)

    Time frame: one year after treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

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 27777031 ↗
  • Boussinesq 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 22530819 ↗
  • Veletzky 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 36121900 ↗
  • Bouchaud 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 31959110 ↗
  • Gardon 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 9217715 ↗
  • Garcia 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06194149
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jan 8, 2024
Start date
Feb 1, 2024 (estimated)
Primary completion
Feb 15, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Jan 8, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion