Short-term Clinical and Bacteriological Efficacy and Safety of Ciprofloxacin for 7 Days versus 14 Days in Women with Acute Pyelonephritis

14 Oct, 20

Background

Acute pyelonephritis is a common and potentially serious infection affecting women of all ages.

To compare the efficacy of ciprofloxacin for 7 days and 14 days in women with community-acquired acute pyelonephritis

Women (aged ≥18 years) who were not pregnant and had a presumptive diagnosis of acute pyelonephritis

The primary endpoint was the clinical and bacteriological outcome 10–14 days after completion of treatment with active drug.
- Clinical cure was defined as complete resolution of symptoms during treatment with no recurrence of symptoms or signs of urinary tract infection during follow-up
- Bacteriological cure was defined as eradication of the infecting strain with no recurrence of bacteriuria (<10? cfu per mL) during follow-up.
The secondary outcome was the long-term cumulative efficacy of ciprofloxacin.

Table 1: Baseline characteristics

	Ciprofloxacin for 7 days (n=73)	Ciprofloxacin for 14 days (n=83)
Age (years)	46	41
Recurrent urinary tract infections	11 (15%)	10 (12%)
Complicated urinary tract infections	4 (5%)	10 (12%)
Diabetes mellitus	2 (3%)	7 (8%)
Temperature (°C)	39·2	39·0
Flank pain or costovertebral angle tenderness	69	79
Serum CRP concentrations (mg/L)	100	125
Pyuria	70 (96%)	78 (94%)
Bacteria isolated from pretreatment urine cultures
Escherichia coli	64 (88%)	79 (95%)
Staphylococcus saprophyticus	3 (4%)	1 (1%)
Klebsiella pneumoniae	3 (4%)	0
Others	3 (4%)	3 (4%)
Positive blood culture	16 (22%)	26 (32%) *
Initial intravenous dose(s) of ciprofloxacin	14 (19%)	11 (13%)

Data are number (%) or median (IQR). All blood cultures grew Escherichia coli. *Blood cultures missing for one patient.

Both treatment regimens resulted in high clinical cure rates at short-term follow-up
The short-term efficacy of 7 days of ciprofloxacin was not inferior to that of 14 days
In patients treated for 7 days and 14 days, the cumulative cure rates were similarly high

Figure 1: Clinical outcomes

Both treatment regimens were well tolerated
Treatment discontinuation because of myalgia was reported in 2 patients with 7 days of treatment and itching exanthema with 14 days
Adverse event after the first week of treatment that was possibly or probably related to the study drug was reported in
- Four (5%) of 86 patients assigned to 7 days of treatment
- Six (6%) of 93 assigned to 14 days
No mucosal candida was reported after the first week in patients assigned to days versus 5 patients assigned to 14 days (p=0·036)

The study showed that 7 days of ciprofloxacin was not inferior to 14 days of treatment.
The clinical and bacteriological cure rates were high for both regimens at short-term and long-term follow-up
The findings suggested that community-acquired acute pyelonephritis in women can be treated successfully and safely with oral ciprofloxacin for 7 days and even in older patients and those with a more severe infection

Lancet 2012; 380: 484–90