A multicentre, double blind, placebo controlled, randomised trial to evaluate the effectiveness of a one-day versus seven-day regimen of nitrofurantoin for the treatment of asymptomatic bacteriuria in pregnancy

ISRCTN	ISRCTN11966080
DOI	https://doi.org/10.1186/ISRCTN11966080
Secondary identifying numbers	A35024

Submission date: 14/12/2007
Registration date: 14/12/2007
Last edited: 30/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Mrs Mariana Widmer
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone	+41 (0)22 791 4323
Email	widmerm@who.int

Study information

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
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
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
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

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	900
Total final enrolment	778
Participant inclusion criteria	1. Pregnant women with gestational age 12 - 32 weeks 2. Willing and able to give consent
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

World Health Organization (WHO) (Switzerland)
Research organisation

Avenue Appia 20
Geneva-27
CH-1211
Switzerland

Phone	+41 (0)22 791 4323
Email	widmerm@who.int
Website	http://www.who.int/reproductive-health/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO) (Switzerland) (ref: A35024)
Private sector organisation / International organizations

Alternative name(s): منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
Location: Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2009	30/12/2020	Yes	No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.