Influence of Trimethoprim-Sulfamethoxazole for the Recurrence of Ocular Toxoplasmosis (ISROT)

July 10, 2016 updated by: Joao Paulo Felix, University of Campinas, Brazil

Influence of Trimethoprim-sulfamethoxazole for the Recurrence of Retinochoroiditis Toxoplasma Gondii

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 in group I and two Group II) with stratification by gender. 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. It was planned a minimum sample of 140 patients (70 in group I and 70 in group II). Assuming an incidence of 6% recurrence in group A, this sample will have a 80% power to detect a difference of 18% between groups. The results of this analysis will be considered significant if p <0.05. The main variables are age, sex, presence of unilateral or bilateral eye injury, number of recurrences, number and location of lesions, and previous treatment for ocular toxoplasmosis. 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. Patients will be trained to return immediately if they have any of the following symptoms: decreased visual acuity, photophobia, floaters or ocular hyperemia. Adverse events will be monitored. The definition of a patient with a recurrent episode of chorioretinitis Toxoplasmosis is the presence of old scars of chorioretinitis, associated with active satellite lesions chorioretinitis with positive IgG for toxoplasmosis. To data collection, will be used semi-structured questionnaire, containing the patient record, age, gender, visual acuity by ETDRS chart, the affected eye and previous treatment for ocular toxoplasmosis.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083570
        • University of Campinas - Ophthalmology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive IgG result for toxoplasmosis (IgG)
  • Ipsilateral scars of retina compatible with previous episode of toxoplasmosis retinochoroiditis
  • Unilateral active lesion of chorioretinitis

Exclusion Criteria:

  • Under 18 years of age
  • Immunosuppressed patients
  • Use of immunosuppressive treatments
  • Concomitant chorioretinitis of other causes
  • Pregnancy
  • Allergy to Sulfonamides

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trimethoprim-Sulfamethoxazole
1 tablet every other day, morning.
Drug: Trimethoprim-Sulfamethoxazole
Sulfamethoxazole 800mg + Trimethoprim 160mg / tablet. In treatment of acute phase, 1 tablet 12/12h 45 days. After acute phase, 1 tablet every other day, morning, 311 days. Placebo tablet - Composition: starch. After acute phase, 1 tablet every other day, morning, 311 days.
Other Names:
  • Sulfamethoxazole 800mg + Trimethoprim 160mg = Bactrim F.
Placebo Comparator: Starch tablet
1 starch tablet every other day, morning.
Drug: Trimethoprim-Sulfamethoxazole
Sulfamethoxazole 800mg + Trimethoprim 160mg / tablet. In treatment of acute phase, 1 tablet 12/12h 45 days. After acute phase, 1 tablet every other day, morning, 311 days. Placebo tablet - Composition: starch. After acute phase, 1 tablet every other day, morning, 311 days.
Other Names:
  • Sulfamethoxazole 800mg + Trimethoprim 160mg = Bactrim F.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Rodrigo PC Lira, PhD, University of Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 10, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 356591

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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