title: A prospective, randomized trial of pyrimethamine and azithromycin vs pyrimethamine and sulfadiazine for the treatment of ocular toxoplasmosis.
abstract: OBJECTIVE
  To compare the effects of two treatment regimens, one of which included azithromycin, for the treatment of sight-threatening (near optic disk or fovea) ocular toxoplasmosis.
  
  
  METHODS
  Prospective, randomized open-labeled multicenter study, masked in part with regard to evaluation.
  
  
  METHODS
  PARTICIPANTS TOTAL ENROLLMENT: 46 patients with sight-threatening ocular toxoplasmosis; pyrimethamine and azithromycin group: 24 patients; pyrimethamine and sulfadiazine group: 22 patients.
  
  
  METHODS
  Patients were randomized into two treatment regimens. Group 1 was treated with pyrimethamine and azithromycin complemented with folinic acid and the addition of prednisone from day 3. Group 2 was treated with pyrimethamine and sulfadiazine complemented with folinic acid and the addition of prednisone from day 3. Patients used study medications daily for 4 weeks. Ocular and laboratory examinations were performed at least weekly during the observation period. The study was masked in part with regard to evaluation.
  
  
  METHODS
  An assessment was made of the time to resolution of the intraocular inflammatory activity, the size of the retinochoroidal lesion, and visual acuity before and after the treatment as well as all adverse effects of treatments.
  
  
  RESULTS
  Adverse effects were more frequent in the pyrimethamine/sulfadiazine group (P <.04), and three patients in this group had to discontinue treatment. The time to resolution of inflammatory activity, decrease in size of retinochoroidal lesions, and optimal visual acuity did not differ between the two treatment groups. The number of patients who developed recurrences during the first year after treatment was similar for both groups.
  
  
  CONCLUSIONS
  The efficacy of the multidrug regimen with pyrimethamine and azithromycin was similar to the standard treatment with pyrimethamine and sulfadiazine. However, the frequency and severity of adverse effects was significantly lower with a regimen containing pyrimethamine and azithromycin. Multidrug therapy with the combination of pyrimethamine and azithromycin appears to be an acceptable alternative for treatment of sight-threatening ocular toxoplasmosis.
authors.affiliation: Uveitis Centre, F.C. Donders Institute of Ophthalmology, University Medical Centre Utrecht, The Netherlands. e.h.boschdriessen@oogh.azu.nl
authors.forename: Lotje H
authors.initials: LH
authors.lastname: Bosch-Driessen
authors.forename: Frank D
authors.initials: FD
authors.lastname: Verbraak
authors.forename: Maria S A
authors.initials: MS
authors.lastname: Suttorp-Schulten
authors.forename: Rutger L J
authors.initials: RL
authors.lastname: van Ruyven
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Klok
authors.forename: Carel B
authors.initials: CB
authors.lastname: Hoyng
authors.forename: Aniki
authors.initials: A
authors.lastname: Rothova
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017963:Azithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011739:Pyrimethamine / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D013411:Sulfadiazine / Q000009:adverse effects / Q000627:therapeutic use*; D014126:Toxoplasmosis, Ocular / Q000188:drug therapy*; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D000900:Anti-Bacterial Agents; D000981:Antiprotozoal Agents; D013411:Sulfadiazine; D017963:Azithromycin; D011739:Pyrimethamine