Optimal duration of antibiotic therapy for uncomplicated

urinary tract infection in older women: a double-blind

randomized controlled trial
Thomas Vogel, et al

Background

The optimal duration of antibiotic therapy in older patients with

uncomplicated urinary tract infection (UTI) is still a matter of debate
A short course of treatment might offer significant advantages in
terms in proved compliance and fewer drug interaction and side effect

Objective

To compare the efficacy and safety of 3 day and 7 day courses of oral
ciprofloxacin for uncomplicated symptomatic UTI in older women.

Method

A double-blind randomized controlled trial

A total of 183 women at least 65 years of age with acute
uncomplicated symptomatic UTI were recruitment
Women were randomly assigned to received either ciprofloxacin 250
mg twice daily orally for 3 day follow by placebo 4 day (93 patients),
and randomly assigned to received ciprofloxacin 250 mg twice daily
orally for 7 day ( 90 patients)
Primary outcome were antimicrobial efficacy at 2 days after
completion of treatment and risk of relaps and reinfection at 6 weeks
after completion of treatment

1
THERAPY WORKSHEET
Citation:

Are the results of this single preventive or therapeutic trial valid?

Was the assignment of patients to Yes, (method)

treatments randomized?
Was the randomization list concealed?
Was follow-up of patients sufficiently long
and complete?
Were all patients analyzed in the groups to
which they were randomized?
Yes, page 470, second paragraph
(method)
Yes, follow up to the patient until 6 weeks
after treatment, no more loss to follow up
20%(to evaluate the long term risk of
relaps and reinfection at 6 weeks after
completion of treatment)
Yes, intention to treat (result)

Were patients, clinicians, and study Yes, double blind

personnel kept blind to treatment?
Were the groups treated equally, apart from
the experimental treatment?
Were the groups similar at the start of the
trial apart from the experimental therapy?
Yes, the group were treated equally, a
part from the experimental treatment, for
3 day and 7 day
Yes, criteria inclusion and eclusion of the
study

Are the valid results of this randomized trial important?

What is the magnitude of the treatment CEER, EER, RRR, ARR, NNT
effect?
How precise is the estimate of the treatment CI
effect?

SAMPLE CALCULATIONS

Occurrence of diabetic Relative risk Absolute risk Number

neuropathy at 5 years reduction (RRR) reduction needed to
among insulin-dependent (ARR) treat (NNT)
diabetics in the DCCT trial
Usual insulin Intensive insulin CER EER CER EER 1/ARR
regimen regimen
control event experimental CER
rate (CER) event rate (EER)
9.6% 2.8% 9.6% 2.8% 9.6% 2.8% 1/6.8%

9.6% =6.8% =15 patients

=71%
95% CI a 4.4% to 9.2% 11 to 23
a
95% confidence interval (CI) on an NNT
=1/(limits on the CI of its ARR)

2
 Bacteri Eradicasi
Yes No Total
Eksperimen (3day) 91 2 93
Control ( 7 day) 83 6 89

YOUR CALCULATIONS

Relative risk Absolute risk Number

reduction (RRR) reduction needed to
(ARR) treat (NNT)
CER EER CER EER CER EER 1/ARR

CER
6/89=0,067 2/93=0,022 0,067-0,022/0,067 0,067-0,022 22
= 0,67
=0,045
=67%

95% CI -0,012 10 to inf

0,105
-22 100%

RRR = 67 % = Terapi pada pasien selama 3 hari dg UTI dapat

menurunkan resiko bacterimia sebanyak 67 % dibandingkan dengan
terapi selama 7 hari

ARR 4,5 % = Perbedaan resiko terapi pasien dengan UTI selama 3

hari dengan terapi selama 7 hari adalah 4,5%

NNT 22 = Kita harus memberikan terapi oral atibiotik pada wanita

sebanyak 20 orang UTI selama 3 hari untuk menhindarkan satu bad
outcome (bacterimia menetap) atau untuk menambah satu
kesembuhan (bacterial eradikasi)

(kesimpulan : penelitian ini cukup important, karena nilai RRR yang

cukup besar dan nilai NNT yang tidak terlalu besar)

Can you apply this valid, important evidence about therapy in caring
for your patient?

Do these results apply to our patient?

Is our patient so different from those in No
the study that its results cannot apply?

Is the treatment feasible in our Yes

setting?

3
 What are our patients potential benefits and harms from the therapy?

Method I : f Risk of the outcome in our patient, relative to

patients in the trial.

Expressed as a decimal:______

NNT/f=____72__/____1__=______ 72

(NNT for patients like ours)

Method II : 1/(PEER RRR) Our patients expected event rate if they
received the control treatment (PEER)
=______

1/(PEER RRR)=1/________=______

(NNT for patients like ours)

Are our patients values and preferences satisfied by the regimen and its consequences?

Yes
Do we and our patient have a clear Yes
assessment of their values and preferences?

Are they met by this regimen and its Yes

consequences?

Additional notes: Terapi pada pasien UTI selam 3+pasebo hari akan lebih
meningkatkan angka kesembuhan meskipun tidak terlalu bermakna dan dengan
terapi 3 hari lebih sedikit yang mengalami gejala sampingan pasien UTI dibandingka
terapi selama 7 hari. (secara ekonomi terapi 3 hari lebih ekonomis dibandingkan
yang 7 hari)