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

ConditionsLoiasis With Positive Blood MicrofilaremiaLoiasis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorProgramme National de Lutte contre l'Onchocercose, Republic of the Congo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Albendazole 400mg

    Drug

    Albendazole 400mg per days for 21 consecutive days

  • Placebo

    Drug

    Placebo for 21 consecutive days

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Albendazole 21 daysExperimental treatment 1 intervention
Group B: Placebo 21 daysPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
During the treatment (21 days) and 3 month after
2

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

Time frame
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

Comparison of occurrence of adverse events by proportion and grade in treatment group (ALB) and placebo group and comparison of DMF reduction rates in L. loa during treatment (D1 to D21) and those observed over the long term (D21 to D180)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Programme National de Lutte contre l'Onchocercose, Republic of the Congo

Lead sponsor

Institut de Recherche pour le Developpement

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: