View clinical trials related to Trachoma.
Filter by:This study will assess the cost and feasibility of two strategies of enhanced Mass Drug Administration (MDA) of Zithromax to treat trachoma in the Republic of South Sudan. The secondary objectives of this study are to measure trachoma infection outcomes during the 12-month follow-up period among children up to 9 years of age.
The present trial is a phase I, double-blind, parallel, randomised, and placebo-controlled trial of a chlamydia vaccine CTH522. Sixty-six subjects will be randomly assigned into six cohorts and are to receive four vaccination, in total of 12 trial visits. Cohorts A-D investigates CTH522-CAF01 administered IM in two doses (85 µg and 15 µg). Cohort E investigate CTH522-CAF09b also administered IM in one dose (85 µg). Cohort E is the placebo group. All subjects will receive a TO administration as a boost at Day 140 (4th vaccination). The TO boost will be non-adjuvanted CTH522 (12µg in each eye) or placebo. Nine subjects in each of cohorts A-E will receive the active boost (i.e. CTH522), three subjects will receive the placebo.
Musca sorbens, a fly that feeds from ocular and nasal discharge on humans, is thought to be the vector of trachoma. We are developing methods of fly control that specifically target this species, in the hope of interrupting Ct transmission. To our knowledge, the use of commercially available insect repellents has never been tested for prevention of Musca sorbens fly-eye contact (i.e. nuisance and landing in the peri-ocular area). Given the likely necessity for prolonged and/or high frequency fly-eye contact for Ct transmission, the reduction of these contacts through the use of fly repellents presents an exciting opportunity for disease control. Here we propose a within-subject, non-masked, trial of the use of commercially available insect repellents against Musca sorbens, with two consecutive participant groups in the laboratory and in the field, and a primary endpoint of measuring the protective efficacy of each repellent product. Repellent products will be chosen from: DEET (N,N-diethyl-3-methylbenzamide), IR3535 (3-[N-butyl-N-acetyl]-aminopropionic acid ethyl ester), Picaridin (2-(2-hydroxyethyl)-1-piperidinecarboxylic acid 1-methylpropyl ester); PMD (para-Menthane-3,8-diol) or permethrin (m-Phenoxybenzyl)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate). Products tested will be either (1) topical repellents, or (2) in long-lasting, plastic formulations of repellents that can be worn on the body (wearable repellent technologies). The insect repellent synergist Vanillin (4-Hydroxy-3-methoxybenzaldehyde) may be added to the long-lasting plastic formulations, to improve the duration of protection.
This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately. Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.
Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole with separate administration of Azithromycin and Ivermectin/Albendazole. The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Within this district, a study group of 8,000 people (in approximately 40 clusters) will receive the azithromycin, ivermectin & albendazole at a single time. A control group of 8,000 people (in approximately 40 clusters) within the same district will receive the current MDA treatment schedule beginning with Ivermectin/Albendazole followed two weeks later with azithromycin. All drug dosing will be in line with standard FMOH and WHO Guidelines for MDA for trachoma and lymphatic filariasis. The study will randomly sort subdistrict communities (Gotes) into the trial arm and the control arm. The study will compare the number of adverse events (AEs) and severe adverse events (SAEs) between the two arms to determine if co-administration is not inferior to the standard treatment. The primary outcome will be to demonstrate the safety of the triple-drug administration as measured by incidence of AEs/SAEs following the MDA.
Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection. The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). Trachoma is more common in villages and households with poor access to water and latrines, so improving the public health infrastructure is thought to be important for limiting transmission of trachoma. However, there is very little evidence to support the efficacy of installing new water points for trachoma. There has been only one previous attempt to study the role of hand dug well installation for trachoma control, and this study, conducted in Niger, found that installing wells was not effective. We now propose a project to improve the public health infrastructure of Goncha Siso Enese woreda by helping with the construction of water points (e.g., hand-dug wells) and providing hygiene education, in order to determine whether improving access to water and hygiene information will be effective for control of trachoma and soil-transmitted helminths.
The investigators aim to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring, leading to better outcomes. As an initial step toward evaluating this modality, the investigators believe it to be necessary to evaluate topical corticosteroid therapy in a safety-oriented study, for which the investigators also hypothesize that fluorometholone will have a perioperative safety profile acceptable for large-scale programmatic use. Topical corticosteroid therapy is associated with potential risks of cataract induction and intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower intraocular penetration than alternative corticosteroids, with correspondingly less IOP-raising effect while still having favorable effects on conjunctival inflammation, and is a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an advantage in this setting, as the major side effects of therapy are the result of intraocular effects, and therapy only is needed to the conjunctiva. However, prior to use in a large-scale trial it is sensible to make sure adverse outcomes are not observed in a substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal dosing schedule and to identify any preliminary signals of potential efficacy.
Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that all communities would have annual rounds of MDA if infection is greater than 1% or follicular trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment program to identify and treat new families and families who travel after mass treatment. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. The proportion of communities that are able to stop mass treatment will be compared in the group of communities randomized to mass treatment plus the newcomer/traveler treatment program compared to the communities randomized to mass treatment alone after 24 months. At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months will be surveyed at 30 months. At risk of trachoma re-infection communities have C. trachomatis infection rates less than or equal to 1% or TF < 5% at the time of the 18 month survey. Surveillance of communities for families that meet the newcomer or traveler status will extend 6 months beyond the 24 month survey to 30 months in the intervention communities only. A survey of sentinel children in the intervention and control communities at 30 months will be conducted to assess the level of trachoma and infection in all 38 communities at risk of trachoma re-emergence.
The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.
Mass antimicrobial administrations have been remarkably successful in reducing the prevalence of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively lower the prevalence of infection, and in some cases may even result in local elimination. Mass treatments cannot be continued forever, due to concerns about cost and antibiotic resistance. The hope has been that other measures such as latrine construction and hygiene programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has yet demonstrated an effect on infection. 1. We hypothesize that Chlamydial infection will return to communities when treatment ends. 2. We hypothesize that infection will be completely eliminated in all communities treated for seven years. 3. We hypothesize that identifying and treating clinically active cases among preschool aged children will delay or even prevent reemergence at a far lower cost than mass treatment of all individuals.