title: Randomized clinical trial on ivermectin versus thiabendazole for the treatment of strongyloidiasis.
abstract: BACKGROUND
  Strongyloidiasis may cause a life-threatening disease in immunosuppressed patients. This can only be prevented by effective cure of chronic infections. Direct parasitologic exams are not sensitive enough to prove cure if negative. We used an indirect immune fluorescent antibody test (IFAT) along with direct methods for patient inclusion and efficacy assessment.
  
  
  RESULTS
  Prospective, randomized, open label, phase III trial conducted at the Centre for Tropical Diseases (Verona, Italy) to compare efficacy and safety of ivermectin (single dose, 200 µg/kg) and thiabendazole (two daily doses of 25 mg/Kg for two days) to cure strongyloidiasis. The first patient was recruited on 6(th) December, 2004. Follow-up visit of the last patient was on 11(th) January, 2007. Consenting patients responding to inclusion criteria were randomly assigned to one of the treatment arms. Primary outcome was: negative direct and indirect (IFAT) tests at follow-up (4 to 6 months after treatment) or subjects with negative direct test and drop of two or more IFAT titers. Considering 198 patients who concluded follow-up, efficacy was 56.6% for ivermectin and 52.2% for thiabendazole (p = 0.53). If the analysis is restricted to 92 patients with IFAT titer 80 or more before treatment (virtually 100% specific), efficacy would be 68.1% for ivermectin and 68.9% for thiabendazole (p = 0.93). Considering direct parasitological diagnosis only, efficacy would be 85.7% for ivermectin and 94.6% for thiabendazole (p = 0.21). In ivermectin arm, mild to moderate side effects were observed in 24/115 patients (20.9%), versus 79/108 (73.1%) in thiabendazole arm (p = 0.00).
  
  
  CONCLUSIONS
  No significant difference in efficacy was observed, while side effects were far more frequent in thiabendazole arm. Ivermectin is the drug of choice, but efficacy of single dose is suboptimal. Different dose schedules should be assessed by future, larger studies.
  
  
  BACKGROUND
  Portal of Clinical Research with Medicines in Italy 2004–004693–87
authors.affiliation: Centre for Tropical Diseases, S. Cuore Hospital, Negrar (Verona), Italy. zeno.bisoffi@sacrocuore.it
authors.forename: Zeno
authors.initials: Z
authors.lastname: Bisoffi
authors.forename: Dora
authors.initials: D
authors.lastname: Buonfrate
authors.forename: Andrea
authors.initials: A
authors.lastname: Angheben
authors.forename: Marina
authors.initials: M
authors.lastname: Boscolo
authors.forename: Mariella
authors.initials: M
authors.lastname: Anselmi
authors.forename: Stefania
authors.initials: S
authors.lastname: Marocco
authors.forename: Geraldo
authors.initials: G
authors.lastname: Monteiro
authors.forename: Maria
authors.initials: M
authors.lastname: Gobbo
authors.forename: Giulia
authors.initials: G
authors.lastname: Bisoffi
authors.forename: Federico
authors.initials: F
authors.lastname: Gobbi
mesh_terms: D000328:Adult; D000818:Animals; D000969:Antinematodal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D005243:Feces / Q000469:parasitology; D005260:Female; D006801:Humans; D007559:Ivermectin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D017171:Strongyloides stercoralis; D013322:Strongyloidiasis / Q000188:drug therapy* / Q000469:parasitology; D013827:Thiabendazole / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000969:Antinematodal Agents; D007559:Ivermectin; D013827:Thiabendazole