Contact information
Type
Scientific
Contact name
Mrs Mariana Widmer
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4323
widmerm@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
A35024
Study information
Scientific title
A multicentre, double blind, placebo controlled, randomised trial to evaluate the effectiveness of a 1-day versus 7-day regimen of nitrofurantoin for the treatment of asymptomatic bacteriuria in pregnancy
Acronym
Study hypothesis
Asymptomatic Bacteriuria (ASB) is defined as the presence of at least 100,000 colony forming units of a urinary pathogen per millilitre in a culture of a midstream urine specimen obtained from an asymptomatic woman on a routine scheduled visit. If this occurs in pregnant women, 20% to 30% of the untreated women may develop pyelonephritis. Of additional concern is the association of low birth weight and preterm delivery with untreated bacteriuria.
Hypothesis:
A one-day regimen of nitrofurantoin (100 mg twice a day) for asymptomatic bacteriuria in pregnant women is as effective as a seven-day regimen for the cure of the condition 14 days later than the first day of treatment.
Ethics approval(s)
Ethics approval received from:
1. World Health Organization (WHO) Ethics Review Committee (ERC) on the 24th November 2003
2. Ethics Committee of the Khon Kaen University on the 17th July 2003 (ref: HE460606)
3. Ethical Committee Ministry of Health Vietnam on the 24th April 2003
4. Ethics Review Board of the College of Medicine - University of the Philippines, Manila on the 28th October 2003
Study design
Randomised double blind placebo controlled clinical trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Asymptomatic Bacteriuria (ASB)
Intervention
Intervention: one-day regimen of nitrofurantoin (100 mg twice a day)
Control: seven-day regimen of nitrofurantoin (100 mg twice a day)
Contact details for Principal Investigator:
Dr Pisake Lumbiganon
Department of Obstetrics and Gynecology
Faculty of Medicine
Khon Kaen University
Khon Kaen, 40002
Thailand
Tel: +66 (0)43 246445
Fax: +66 (0)43 348395
Email: pisake@kku.ac.th
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Nitrofurantoin
Primary outcome measure
Bacteriological cure after the antibiotic treatment based on the result of midstream urine culture 14 days after the initiation of the treatment.
Secondary outcome measures
Incidences of:
1. Pyelonephritis
2. Preterm delivery
3. Low birth weight
4. Side effects
Overall study start date
01/03/2004
Overall study end date
01/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant women with gestational age 12 - 32 weeks
2. Willing and able to give consent
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
900
Total final enrolment
778
Participant exclusion criteria
1. Have any underlying disease, which require continuous steroid and/or antibiotic treatment, e.g. systemic lupus erythematosus, valvular heart disease, etc.
2. Use of any antibiotics during the past one-week
3. Received any treatment for urinary tract infection at any time during the current pregnancy
4. History of nitrofurantoin hypersensitivity
5. Plan not to deliver at the study hospital
6. Any symptoms such as flank pain, dysuria that suggests symptomatic Urinary Tract Infections (UTI)
7. Have any haematological disease including Glucose-6-Phosphate Dehydrogenase deficiency (G6PD)
8. Negative urine dipslide
9. Negative urine culture
10. Positive urine culture but the organism is resistant to Nitrofurantoin
Recruitment start date
01/03/2004
Recruitment end date
01/03/2007
Locations
Countries of recruitment
Argentina, Philippines, Switzerland, Thailand, Viet Nam
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4323
widmerm@who.int
Sponsor type
Research organisation
Website
http://www.who.int/reproductive-health/
ROR
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland) (ref: A35024)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2009 | 30/12/2020 | Yes | No |