COPD: ceftibuten caused fewer adverse effects than clarithromycin.

Clinical bottom line (level 1b)

Patients with an acute exacerbation of chronic bronchitis who were given ceftibuten, had no clear difference in clinical success or relapse than those given clarithromycin.
Patients given ceftibuten were less likely to have adverse effects than those given clarithromycin (NNT = 6 at 7 days) .

Ziering and McElvaine: Infection 1998; 26: 72-79

Expires May 2003

The study

Single-blinded ?concealed randomised trial with intention-to-treat
Setting: multicentre, USA

308 patients (aged range 19 to 84 years; mean 49, 56% female) Established diagnosis of chronic bronchitis (chronic cough with sputum production on most days over a period of 3 months for at least 2 consecutive years) and an acute exacerbation (worsening cough, dyspnoea, increased volume of expectorated sputum or increased sputum purulence).

Excluded if

<18 years old

pneumonia

hypersensitivity to penicillins, cephalosporins or macrolide antibiotics

hepatic impairment (alanine aminotransferase or aspartate aminotransferase >3 times normal, bilirubin concentration = 4.0 mg/dL, neutropenia, neutrophils = 1000/mm ł )

renal disease (serum creatinine = 2.0 mg/dL)

treatment with any other antimicrobial agent = 3 days before study start or during treatment with study drug

immunocompromised

cancer

infection with pathogens known to be resistant to ceftibuten or clarithromycin

previous treatment with either study drug

severe respiratory tract disease requiring hospitalisation or use of parenteral antibiotics

evidence of residual infection after previous antibiotic treatment

chronic or severe diarrhoea or diarrhoea of >5 days' duration before enrolment

treatment with oral or systemic corticosteroids within 30 days of enrolment or alteration in inhaled corticosteroids dose within the same period

treatment with theophylline, terfenadine or carbamazepine

pregnancy or lactation

any other condition or circumstances known by the physician that would make the patient unsuitable for treatment

Note:

80% of patients were white.

Control Group: (n = 153, 140 analysed): clarithromycin 500 mg twice daily (BID) for a between 7 and 14 days
Experimental Group: (n = 156, 139 analysed): ceftibuten 500 mg once daily (QD) for between 7 and 14 days

99% followed for ? days
Outcome notes:

clinical success : Cure- resolution of acute signs and symptoms with a return to pre-infection levels of cough, dyspnoea and sputum production, with absence of fever; or improvement- subjective improvement in acute signs and symptoms, but without return to pre-infection state

The evidence

Outcome	Time to outcome	CER	EER	RRR (95% CI)	ARR (95% CI)	NNT (95% CI)
clinical success	days	127 (90.71%)	127 (91.37%)	7% (-87% to 56%)	0.65% (-6.05% to 7.35%)	153 (NNT = 14 to infinity; NNH = 17 to infinity)
relapse	days	9 (6.43%)	9 (6.47%)	-1% (-146% to 59%)	-0.05% (-5.81% to 5.72%)	-2162 (NNT = 17 to infinity; NNH = 17 to infinity)
adverse effects	7 days	33 (21.9%)	8 (5.26%)	76.0% (49% to 88.0%)	17.82% (9.10% to 24.1%)	6 (4 to 10)

Clinical success was determined at between 0 and 6 days after treatment ended.

Citation

Ziering W, and McElvaine P: Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis. Infection 1998; 26: 72-79

Search Terms: chronic bronchitis and therapy in Medline
Contributor: Clare Wotton and Musab Hayatli, November 1999
Reviewer:

_{Clinical Question.}

_Patient	_{acute exacerbation of chronic bronchitis}
_{Intervention or Exposure}	_ceftibuten
_Comparison	_{clarithromycin}
_Outcome	_{clinical success}