Randomised controlled clinical trial of increased dose and frequency of XXXX and @entity3070 on Wuchereria bancrofti microfilarial clearance in northern Malawi.

@entity3753 @entity1 @entity3754 @entity3070
BACKGROUND: In Africa, @entity3753 and @entity3070 are currently used in combination for annual mass drug administration (MDA) for @entity3754 ( @entity3754 ) elimination. Rapid and sustained clearance is desirable for public health impact and elimination of @entity3754 . Increasing the dose and/or frequency of @entity3753 and @entity3070 treatment may be more effective in clearing microfilariae than standard MDA. METHODS: We conducted a randomised controlled open label trial in northern Malawi comparing three modified treatment groups to standard dosage of @entity3070 and @entity3753 in adults with confirmed circulating @entity3754 antigen and microfilaria. @entity1 were followed-up every 6 months for 2 years for repeat microfilarial counts and safety assessments. RESULTS: A total of 1851 adults were screened and 70 with microfilarial counts >80 microfilariae/ml were randomised. All treatment groups achieved a significant reduction of microfilariae levels by 12- and 24-months of follow-up. Doubling the standard dose and administering it twice yearly showed a non-significant tendency towards faster and more complete clearance. There were no serious adverse reactions. CONCLUSIONS: In this small study, all regimens effectively cleared microfilaria. Standard treatment may be adequate in settings like Malawi but not in all endemic settings and larger studies are required to demonstrate benefit of higher dosages. [ClinicalTrials.gov identifier: NCT01213576].
