title: Tolerability of azithromycin as malaria prophylaxis in adults in northeast papua, indonesia.
abstract: Drug tolerability affects compliance. We evaluated the tolerability levels of azithromycin (750-mg loading dose plus 250 mg/day; n = 148 subjects), doxycycline (100 mg/day; n = 75), and placebo (n = 77) as prophylaxis against malaria in Indonesian adults over 20 weeks. Self-reported and elicited symptoms, health perception, hearing, hematology, and biochemistry were assessed. The loading dose was well tolerated. The frequencies (number per person-years [p-yr]) of all daily reported symptoms were similar in the three arms of the study: 40.2/p-yr for azithromycin, 39.7/p-yr for doxycycline, and 38.2/p-yr for placebo. Relative to those who received placebo, azithromycin recipients complained more often of heartburn (rate ratio = 10.5 [95% confidence interval, 2.8 to 88.1]), paresthesia (2.03 [1.08 to 4.24]), and mild (1.55 [1.01 to 2.48]) and severe (11.2 [1.34 to infinity ]) itching but less often of fever (0.21 [0.09 to 0.49]) and tinnitus (0.09 [0.04 to 0.21]). Azithromycin recipients showed no evidence of clinical hearing loss or hematologic, hepatic, or renal toxicity. One azithromycin recipient developed an erythematous rash. Daily azithromycin was well tolerated by these Indonesian adults during 20 weeks of treatment.
authors.affiliation: U.S. Naval Medical Research Unit No 2 , National Institutes of Health, Jakarta, Indonesia. taylorw@who.ch
authors.forename: Walter R
authors.initials: WR
authors.lastname: Taylor
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Richie
authors.forename: David J
authors.initials: DJ
authors.lastname: Fryauff
authors.forename: Colin
authors.initials: C
authors.lastname: Ohrt
authors.forename: Helena
authors.initials: H
authors.lastname: Picarima
authors.forename: Douglas
authors.initials: D
authors.lastname: Tang
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Murphy
authors.forename: Hendra
authors.initials: H
authors.lastname: Widjaja
authors.forename: David
authors.initials: D
authors.lastname: Braitman
authors.forename: Emiliana
authors.initials: E
authors.lastname: Tjitra
authors.forename: Asep
authors.initials: A
authors.lastname: Ganjar
authors.forename: Trevor R
authors.initials: TR
authors.lastname: Jones
authors.forename: Hasan
authors.initials: H
authors.lastname: Basri
authors.forename: Josh
authors.initials: J
authors.lastname: Berman
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D017963:Azithromycin / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007214:Indonesia; D016778:Malaria, Falciparum / Q000517:prevention & control*; D008297:Male; D010349:Patient Compliance; D011795:Surveys and Questionnaires
chemical_list: D000900:Anti-Bacterial Agents; D017963:Azithromycin