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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Campinas, Brazil.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Joao Paulo Felix, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01449877
First received: October 6, 2011
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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 consist 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 (prophylactic treatment with trimethoprim-sulfamethoxazole tablet every other day) or group 2 (consisting of a placebo pill containing no active ingredient of similar appearance to trimethoprim-sulfamethoxazole, 1 time a day to day alternate). The definition of a patient with a recurrent episode of chorioretinitis Toxoplasmosis is the presence of old scars of chorioretinitis, associated with satellite active lesions chorioretinitis with positive IgG and IgM negative for toxoplasmosis. 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 outcome is incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 12 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.


Condition Intervention Phase
Ocular Toxoplasmosis
Drug: Trimethoprim-Sulfamethoxazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Influence of Trimethoprim-sulfamethoxazole for the Recurrence of Retinochoroiditis Toxoplasma Gondii

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 12 months. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. Placebo tablet - Composition: starch. After acute phase, 1 tablet every other day, morning.
Other Name: Sulfamethoxazole 800mg + Trimeethoprim 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. Placebo tablet - Composition: starch. After acute phase, 1 tablet every other day, morning.
Other Name: Sulfamethoxazole 800mg + Trimeethoprim 160mg = Bactrim F.

Detailed Description:

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 two years in uveitis clinic at intervals defined as follows: return weekly for 4 weeks, monthly for 3 months and finally, 3/3 months. 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 and IgM negative 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive test results for toxoplasmosis(IgM or IgG)
  • Scars of retina compatible with toxoplasmosis
  • Active lesion of chorioretinitis

Exclusion Criteria:

  • Under 18 years of age
  • Immunosuppressed patients
  • Use of immunosuppressive treatments
  • Concomitant chorioretinitis of other causes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449877

Contacts
Contact: João Paulo F. Felix 19 3521 7396 joaopaulofelix@hotmail.com
Contact: Rodrigo Pessoa C. Lira 19 3521 7337 rodrigopclira@hotmail.com

Locations
Brazil
University of Campinas - Ophthalmology Department Recruiting
Campinas, São Paulo, Brazil, 13083570
Contact: João Paulo F. Felix    19 3521 7396    joaopaulofelix@hotmail.com   
Contact: Rodrigo Pessoa C. Lira       rodrigopclira@hotmail.com   
Principal Investigator: João Paulo F Felix, Resident         
Principal Investigator: Rodrigo P C Lira, PhD         
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Rodrigo PC Lira, PhD University of Campinas
  More Information

Additional Information:
Publications:
Responsible Party: Joao Paulo Felix, MD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01449877     History of Changes
Other Study ID Numbers: 356591
Study First Received: October 6, 2011
Last Updated: June 12, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
Ocular Toxoplasmosis
Retinochoroiditis
Prophylaxis

Additional relevant MeSH terms:
Chorioretinitis
Recurrence
Toxoplasmosis
Toxoplasmosis, Ocular
Retinitis
Retinal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Panuveitis
Uveitis
Disease Attributes
Pathologic Processes
Coccidiosis
Protozoan Infections
Parasitic Diseases
Eye Infections, Parasitic
Eye Infections
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents

ClinicalTrials.gov processed this record on August 21, 2014