A Phase 4 interventional study of azithromycin and ivermectin in Trachoma and Lymphatic Filariasis, sponsored by Emory University. Withdrawn at 1 site in Mozambique. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-22.
Sponsored by Emory University · Phase 4 and Interventional
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.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
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Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Investigational drug or device
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Clinically significant
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Combination treatment with azithromycin, ivermectin and albendazole on day 1, followed by placebo on day 8 Placebo has same appearance and dosing as azithromycin.
Drug: azithromycin · Drug: ivermectin · Drug: albendazole · Drug: placebo
Standard treatment with placebo, ivermectin and albendazole on day 1, followed by azithromycin on day 8 Placebo has same appearance and dosing as azithromycin.
Drug: azithromycin · Drug: ivermectin · Drug: albendazole · Drug: placebo
The overall rate of adverse events and serious adverse events in each group
Time frame: 15 days
The types of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The incidences of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The timing of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The duration of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The intensities of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Azithromycin · Ivermectin · Albendazole