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

Launched by PROGRAMME NATIONAL DE LUTTE CONTRE L'ONCHOCERCOSE, REPUBLIC OF THE CONGO · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called albendazole can safely reduce the number of Loa loa parasites in adults who have a condition called loiasis, which is caused by these parasites in the bloodstream. Participants will take 400 mg of albendazole daily for three weeks. The trial aims to see if this treatment is effective and safe.

To be eligible for the trial, participants must be adults aged 18 to 70 who weigh between 40 kg and 90 kg and have been diagnosed with Loa loa microfilaremia. Potential participants should also be in good health and not have certain medical conditions or recent treatments that could affect the study's results. Those who join the trial will receive either the medication or a placebo (a non-active treatment) but won't know which one they are getting. This helps researchers understand how well the treatment works. It's important for anyone considering this trial to discuss any questions or concerns with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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)
• • On clinical examination: symptoms, physical signs or laboratory findings suggestive of systemic disorders, including disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other abnormalities that could interfere with the interpretation of trial results. The physician may then give a favorable or unfavorable opinion on the participants inclusion.
• • 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
• • Positive urine pregnancy test for women of childbearing age or breastfeeding