Influence of Trimethoprim-Sulfamethoxazole for the Recurrence of Ocular Toxoplasmosis

NCT01449877 | Completed Phase 3 DMC

• 1 other identifier: 356591
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Toxoplasmosis

Keywords

Ocular Toxoplasmosis; Retinochoroiditis; Prophylaxis

Outcome Measures

Primary Outcomes (9)

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 12 months.

  One year

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 36 months.

  Three years

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 48 months.

  Four years

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 60 months.

  Five years

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 72 months.

  Six years

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 84 months.

  Seven years

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 96 months.

  Eight years

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 108 months.

  Nine years

• Incidence of episodes of recurrent chorioretinitis by toxoplasmosis in the follow up of 120 months.

  Ten years

Study Arms (2)

Trimethoprim-Sulfamethoxazole

ACTIVE COMPARATOR

1 tablet every other day, morning.

Drug: Trimethoprim-Sulfamethoxazole

Starch tablet

PLACEBO COMPARATOR

1 starch tablet every other day, morning.

Drug: Trimethoprim-Sulfamethoxazole

Interventions

Trimethoprim-Sulfamethoxazole DRUG

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.

Also known as: Sulfamethoxazole 800mg + Trimethoprim 160mg = Bactrim F.

Starch tablet; Trimethoprim-Sulfamethoxazole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Campinas - Ophthalmology Department

Campinas, São Paulo, 13083570, Brazil

Location

Related Publications (4)

• Opremcak EM, Scales DK, Sharpe MR. Trimethoprim-sulfamethoxazole therapy for ocular toxoplasmosis. Ophthalmology. 1992 Jun;99(6):920-5. doi: 10.1016/s0161-6420(92)31873-1.

  PMID: 1630782 BACKGROUND

• Soheilian M, Sadoughi MM, Ghajarnia M, Dehghan MH, Yazdani S, Behboudi H, Anisian A, Peyman GA. Prospective randomized trial of trimethoprim/sulfamethoxazole versus pyrimethamine and sulfadiazine in the treatment of ocular toxoplasmosis. Ophthalmology. 2005 Nov;112(11):1876-82. doi: 10.1016/j.ophtha.2005.05.025. Epub 2005 Sep 19.

  PMID: 16171866 BACKGROUND

• Gilbert RE, See SE, Jones LV, Stanford MS. Antibiotics versus control for toxoplasma retinochoroiditis. Cochrane Database Syst Rev. 2002;(1):CD002218. doi: 10.1002/14651858.CD002218.

  PMID: 11869630 BACKGROUND

• Silveira C, Belfort R Jr, Muccioli C, Holland GN, Victora CG, Horta BL, Yu F, Nussenblatt RB. The effect of long-term intermittent trimethoprim/sulfamethoxazole treatment on recurrences of toxoplasmic retinochoroiditis. Am J Ophthalmol. 2002 Jul;134(1):41-6. doi: 10.1016/s0002-9394(02)01527-1.

  PMID: 12095806 RESULT

Related Links

• University of Campinas

MeSH Terms

Conditions

Toxoplasmosis, Ocular; Chorioretinitis

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole; Trimethoprim

Condition Hierarchy (Ancestors)

Eye Infections, Parasitic; Parasitic Diseases; Infections; Toxoplasmosis; Coccidiosis; Protozoan Infections; Eye Infections; Eye Diseases; Retinitis; Retinal Diseases; Choroiditis; Choroid Diseases; Uveal Diseases; Uveitis, Posterior; Panuveitis; Uveitis

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Rodrigo PC Lira, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 10, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

BR (1)