Single-dose Azithromycin for the Treatment of Yaws

PHASE3CompletedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
YawsTreponema InfectionNeglected Tropical Disease
Interventions
DRUG

Penicillin-G-benzathine

"Screening examination: Medical history (emphasis on skin lesions and bone signs) Physical examination.Blood samples for VDRL and TPHA. Clinical safety. Laboratory evaluations: haemoglobin, total WBC count, differential WBC count, platelet count, ALT, AST, urea and creatinine.~Routine assessments: General clinical assessment and physical examination on Days 0 (treatment administered) and 14. Adverse events and concomitant medications (at baseline, Day 14 and in any unscheduled visit). Photograph documentation of skin lesions (at 14 days follow up visit). Follow-up visits performed on 3 and 6 will have a ± 14 days allowable window"

DRUG

Azithromycin

"Screening examination: Medical history (emphasis on skin lesions and bone signs) Physical examination.Blood samples for VDRL and TPHA. Clinical safety. Laboratory evaluations: haemoglobin, total WBC count, differential WBC count, platelet count, ALT, AST, urea and creatinine.~Routine assessments: General clinical assessment and physical examination on Days 0 (treatment administered) and 14. Adverse events and concomitant medications (at baseline, Day 14 and in any unscheduled visit). Photograph documentation of skin lesions (at 14 days follow up visit). Follow-up visits performed on 3 and 6 will have a ± 14 days allowable window"

Trial Locations (1)

034

Lihir Medical Centre, Kavieng

Sponsors
All Listed Sponsors
collaborator

Centre For International Health

OTHER

lead

Lihir Medical Centre

OTHER