Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis
Status:
Withdrawn
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs),
infectious diseases that affect millions of poor people in countries in the developing world.
Trachoma is an eye infection that can lead to painful scarring of the eyelids and blindness
later in life. LF can lead to swelling of usually the limbs (elephantiasis).
Trachoma and LF are preventable and treatable diseases. One important treatment strategy is
annual Mass Drug Administration (MDA): Communities receive drug treatment once a year.
Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF.
Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for
trachoma and LF, where three drugs would be given at one time, would reduce costs and
decrease the burden on the health system.
Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be
recommended, we would have to demonstrate that the safety profile of this treatment with
three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA
(one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the
same day) showed that the safety profiles were comparable; but the results of the study were
not statistically significant and we could not use them to make an official recommendation.
The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL
study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable,
an official recommendation for combined MDA with azithromycin, ivermectin and albendazole can
be drafted.
We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and
exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5
years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding.
Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller clusters
for sufficient power (average household size is 5 people), b) placebo to double-blind
participants and study staff for azithromycin, c) the study area will have undergone fewer
previous rounds of MDA for LF and none for trachoma, and d) smartphones for data entry.