An open clinical trial of nifurtimox for arseno-resistant Trypanosoma brucei gambiense sleeping sickness in central Zaire.
Twenty-five patients with arseno-resistant Trypanosoma brucei gambiense sleeping sickness were treated with oral nifurtimox, 12-17 mg/kg/d for 60 d. During treatment, trypanosomes disappeared from the cerebrospinal fluid (CSF) of 7/7 patients; the CSF infections; leucocyte was significantly lower at the end of treatment than before it was begun (pre-nifurtimox: 124.2 (+/- 149.3) per microliter; post-nifurtimox: 11.9 (+/- 12.1) per microliter; P less than 0.001). Nifurtimox was well tolerated, with gastro-intestinal disturbances in 6 patients and a reversible cerebellar syndrome in 2 patients. Among the 19 patients seen at least once at follow-up, 12 (63%) relapsed. The other 7 patients have been followed for 3-18 months, and the CSF remained completely normal in 4 of them. This study confirms that nifurtimox has some activity against T.b. gambiense, but a daily dosage higher than 15 mg/kg/d will be necessary to achieve cure of most patients.
Pepin
J
J
University of Manitoba, Winnipeg, Canada.
Milord
F
F
Mpia
B
B
Meurice
F
F
Ethier
L
L
DeGroof
D
D
Bruneel
H
H
D000293:Adolescent; D000818:Animals; D002526:Cerebellar Diseases / Q000139:chemically induced; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D015023:Democratic Republic of the Congo; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007223:Infant; D007958:Leukocyte Count; D008297:Male; D009547:Nifurtimox / Q000009:adverse effects / Q000627:therapeutic use*; D009581:Nitrofurans / Q000627:therapeutic use*; D013997:Time Factors; D014347:Trypanosoma brucei gambiense; D014353:Trypanosomiasis, African / Q000134:cerebrospinal fluid / Q000188:drug therapy*
D009581:Nitrofurans; D009547:Nifurtimox