Generic versus non-generic formulation of extended-release clarithromycin in patients with community-acquired respiratory tract infections: a prospective, randomized, comparative, investigator-blind, multicentre study.
OBJECTIVE
There is a general concern about the use of multisource (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modified-release formulations of clarithromycin (i.e. the originator Klacid XL and the generic Klarithran MR) were compared in patients with acute community-acquired respiratory tract infections.


METHODS
Patients presenting with tonsillopharyngitis, sinusitis or pneumonia were randomized to receive either of the test drugs provided they clinically qualified for empirical clarithromycin treatment. The study endpoints were clinical and bacteriological cure rates, tolerability and safety. The study was designed to test for non-inferiority with regard to cure rates.


RESULTS
The main outcome of this study was that both agents had similar clinical (non-inferior) and bacteriological cure rates and demonstrated no difference in tolerability in patients. The study also demonstrated the clinical efficacy of clarithromycin when used as empirical treatment in patients with respiratory tract infections in community practice (i.e. 95% clinical cure rate).


CONCLUSIONS
The clarithromycin extended-release multisource product (Klarithran MR) does not differ significantly from the originator (Klacid XL) and the clinical cure rate of the generic formulation is non-inferior to that of the originator. The two formulations are tolerated similarly.
Snyman
J R
JR
Department of Pharmacology, School of Medicine, University of Pretoria, Pretoria, South Africa. jacquesS@healthcorp.co.za
Schoeman
H S
HS
Grobusch
M P
MP
Henning
M
M
Rabie
W
W
Hira
M
M
Parshotam
K
K
Mithal
Y
Y
Singh
S
S
Ramdas
Z
Z
D000284:Administration, Oral; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017291:Clarithromycin / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017714:Community-Acquired Infections; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D016568:Drugs, Generic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000382:microbiology*; D016037:Single-Blind Method; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D017291:Clarithromycin