title: Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness.
abstract: OBJECTIVE
  Assessment of the safety and efficacy of a 10-day melarsoprol schedule in second stage T.b. rhodesiense patients and the effect of suramin-pretreatment on the incidence of encephalopathic syndrome (ES) during melarsoprol therapy.
  
  
  METHODS
  Sequential conduct of a proof-of-concept trial (n = 60) and a utilization study (n = 78) using historic controls as comparator.
  
  
  METHODS
  Two trial centres in the T.b. rhodesiense endemic regions of Tanzania and Uganda.
  
  
  METHODS
  Consenting patients with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and pregnant patients were excluded.
  
  
  METHODS
  The primary outcome measures were safety and efficacy at end of treatment. The secondary outcome measure was efficacy during follow-up after 3, 6 and 12 months.
  
  
  RESULTS
  The incidence of ES in the trial population was 11.2% (CI 5-17%) and 13% (CI 9-17%) in the historic data. The respective case fatality rates were 8.4% (CI 3-13.8%) and 9.3% (CI 6-12.6%). All patients discharged alive were free of parasites at end of treatment. Twelve months after discharge, 96% of patients were clinically cured. The mean hospitalization time was reduced from 29 to 13 days (p<0.0001) per patient.
  
  
  CONCLUSIONS
  The 10-day melarsoprol schedule does not expose patients to a higher risk of ES or death than does treatment according to national schedules in current use. The efficacy of the 10-day melarsoprol schedule was highly satisfactory. No benefit could be attributed to the suramin pre-treatment.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN40537886.
authors.affiliation: Swiss Tropical and Public Heath Institute, Basel, Switzerland. irene.kuepfer@unibas.ch
authors.forename: Irene
authors.initials: I
authors.lastname: Kuepfer
authors.forename: Caecilia
authors.initials: C
authors.lastname: Schmid
authors.forename: Mpairwe
authors.initials: M
authors.lastname: Allan
authors.forename: Andrew
authors.initials: A
authors.lastname: Edielu
authors.forename: Emma P
authors.initials: EP
authors.lastname: Haary
authors.forename: Abbas
authors.initials: A
authors.lastname: Kakembo
authors.forename: Stafford
authors.initials: S
authors.lastname: Kibona
authors.forename: Johannes
authors.initials: J
authors.lastname: Blum
authors.forename: Christian
authors.initials: C
authors.lastname: Burri
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001927:Brain Diseases / Q000209:etiology; D002648:Child; D004334:Drug Administration Schedule; D019353:Endemic Diseases; D005260:Female; D006801:Humans; D008297:Male; D008549:Melarsoprol / Q000008:administration & dosage* / Q000009:adverse effects*; D008875:Middle Aged; D013498:Suramin / Q000627:therapeutic use; D013636:Tanzania / Q000453:epidemiology; D014344:Trypanocidal Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D016833:Trypanosoma brucei rhodesiense; D014353:Trypanosomiasis, African / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D014454:Uganda / Q000453:epidemiology
chemical_list: D014344:Trypanocidal Agents; D013498:Suramin; D008549:Melarsoprol