21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia

NCT06613997 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: Protocole 129
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our aim is to test the hypothesis that a 3-week course of albendazole 400 mg daily is safe and can progressively reduce Loa loa microfilarial densities in subjects with microfilaremia.

Conditions

Loiasis With Positive Blood Microfilaremia; Loiasis

Keywords

filariasis; Albendazole; Onchocerciasis

Outcome Measures

Primary Outcomes (2)

• Tolerance of Albendazole 400mg/day in individuals with Loa loa microfilaremia

  The proportion of AEs and/or SAEs occurring in the treatment (ALB) and placebo groups and the proportion of AEs and/or SAEs occurring by grade in the treatment (ALB) and placebo groups

  During the treatment (21 days) and 3 month after

• Efficacity of Albendazole 400mg/day in individuals with Loa loa microfilaremia

  Rate of reduction of L. loa DMF in blood at D2, D7, D15, D22, D30, D90 and D180 in each of the two groups and proportion of subjects without L. loa microfilariae in blood at D2, D7, D15, D22, D30, D90 and D180 in both groups

  During the treatment (21 days) and 6 months after

Secondary Outcomes (1)

• Comparison the safety of albendazole to placebo in individuals with Loa loa microfilaremia

  From Day 2 after the first dose to 6 months after the first dose

Study Arms (2)

Albendazole 21 days

EXPERIMENTAL

Participants randomized in this arm will receive 21 days of albendazole 400mg/days .

Drug: Albendazole 400mg

Placebo 21 days

PLACEBO COMPARATOR

Participants randomized in this arm will receive 21 days of placebo.

Drug: Placebo

Interventions

Albendazole 400mg DRUG

Albendazole 400mg per days for 21 consecutive days

Albendazole 21 days

Placebo DRUG

Placebo for 21 consecutive days

Placebo 21 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent informed, written, signed and dated
• Women or men aged 18 to 70 years inclusive
• Carrier of L. loa microfilaremia
• Body weight ≥ 40 kg and less than 90 kg

You may not qualify if:

• Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of albendazole placebo)
• Any vaccination within 4 weeks previous to this study
• Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
• Known immunosuppressive pathology (by self-report)
• Past or present history of neurological (including epilepsy) or neuropsychiatric disease
• Current treatment with ritonavir and/or rifampicin
• Use of cocaine or other drugs of abuse in the 72 hours preceding administration of the trial treatment, as determined by history during the medical interview
• Past or present history of liver, kidney or bone marrow failure
• ALAT transaminase level ≥ 3 times the upper limit of normal (3N) according to laboratory standards
• Any condition, in the opinion of the investigator, that exposes the subject to undue risk
• Known intolerance to ALB or benzimidazole derivatives in general
• Subjects who donated blood in the previous 8 weeks to study entry, with a standard volume (500 mL)
• ALB and/or mebendazole in the last month
• IVM taken in the last month
• Any condition which, in the opinion of the investigator, exposes the subject to undue risk

Sponsors & Collaborators

• Programme National de Lutte contre l'Onchocercose, Republic of the Congo: lead
• Institut de Recherche pour le Developpement: collaborator

MeSH Terms

Conditions

Loiasis; Filariasis; Onchocerciasis

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jéremy CAMPILLO, PharmD PhD

  Institut de Recherche pour le Développement (IRD)

  STUDY DIRECTOR

• François MISSAMOU, MD

  Programme National de Lutte contre l'Onchocercose (PNLO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jéremy CAMPILLO, PharmD PhD

CONTACT

+33 4 67 41 61 52; jeremy.campillo@ird.fr

Bachiratou SAHM

CONTACT

bachiratou.sahm@ird.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A 2-group, randomized, double-blind, parallel clinical trial: * albendazole 400 mg daily for 21 consecutive days * Placebo, daily for 21 consecutive days

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share