Clinical Trial: Influence of Trimethoprim-Sulfamethoxazole for the Recurrence of Ocular Toxoplasmosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Influence of Trimethoprim-sulfamethoxazole for the Recurrence of Retinochoroiditis Toxoplasma Gondii

Brief Summary: The investigators study aims to determine the effect of prophylactic therapy with Trimethoprim-sulfamethoxazole on the recurrences of toxoplasma retinochoroiditis gondii. This is a randomized, double-masked, in patients with eye condition of acute Toxoplasma gondii retinochoroiditis. Volunteers will be recruited with a previous diagnosis of chorioretinitis presumed Toxoplasma gondii, which show active lesions compatible with recurrence. After the acute phase of treatment of all patients [1 tablet Trimethoprim-sulfamethoxazole (800/160mg) 12/12h during 45 days], the same Stratified by gender) will be randomized in a 1:1 ratio between the group 1 - TMP-SMZ (prophylactic treatment with trimethoprim-sulfamethoxazole 1 tablet every other day for 311 days) or group 2 - placebo (consisting of a placebo pill containing no active ingredient of similar appearance to trimethoprim-sulfamethoxazole, 1 tablet every other day for 311 days). The primary outcomes are incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 12, 36, 48, 60, 72, 84, 96, 108, and 120 months. Patients will be followed during the ten years in uveitis clinic at intervals defined as follows: return weekly for 4 weeks, then monthly for 2 months, then each 3 months for 9 months, and finally annually for 10 years.

Detailed Summary: The protozoan Toxoplasma gondii is an obligate intracellular parasite, a common cause of intraocular inflammation in the world. The treatment of toxoplasmosis is the sulfonamide group of drugs, which acts on tachyzoites forms, no acting on bradyzoites, that grown from latent focus located on boards and are responsible for recurrence. The investigators study aims to determine the effect of prophylactic therapy with Trimethoprim-sulfamethoxazole on the recurrences of toxoplasma retinochoroiditis gondii. This is a randomized, double-masked, in patients with eye condition of acute Toxoplasma gondii retinochoroiditis. The study population consists of patients treated at Ophthalmology department, University of Campinas. They present symptoms compatible with a diagnosis of recurrent ocular toxoplasmosis. Volunteers will be recruited with a previous diagnosis of chorioretinitis presumed Toxoplasma gondii, which show active lesions compatible with recurrence. After the acute phase of treatment of all patients [1 tablet Trimethoprim-sulfamethoxazole (800/160mg) 12/12h during 45 days], the same Stratified by gender) will be randomized in a 1:1 ratio between the group 1 - TMP-SMZ (prophylactic treatment with trimethoprim-sulfamethoxazole 1 tablet every other day for 311 days) or group 2 - placebo (consisting of a placebo pill containing no active ingredient of similar appearance to trimethoprim-sulfamethoxazole, 1 tablet every other day for 311 days). The definition of a patient with recurrent episode of chorioretinitis Toxoplasmosis is the presence of old scars of chorioretinitis, associated with satellite active lesions chorioretinitis with positive IgG for toxoplasmosis. The new recurrence was treated with 1 tablet Trimethoprim-sulfamethoxazole (800/160mg) 12/12h during 45 days. The patients will be tested for visual acuity, examination biomicroscopy, tonometry, fundus photography and indirect ophthalmoscopy. In each study, patients will be randomized in blocks of four (two
Sponsor: University of Campinas, Brazil

Current Primary Outcome:

  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 12 months. [ Time Frame: One year ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 36 months. [ Time Frame: Three years ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 48 months. [ Time Frame: Four years ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 60 months. [ Time Frame: Five years ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 72 months. [ Time Frame: Six years ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 84 months. [ Time Frame: Seven years ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 96 months. [ Time Frame: Eight years ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 108 months. [ Time Frame: Nine years ]
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 120 months. [ Time Frame: Ten years ]


Original Primary Outcome: Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 12 months. [ Time Frame: One year ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Campinas, Brazil

Dates:
Date Received: October 6, 2011
Date Started: October 2011
Date Completion:
Last Updated: July 10, 2016
Last Verified: July 2016