Condition category
Infections and Infestations
Date applied
14/12/2007
Date assigned
14/12/2007
Last edited
15/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

A35024

Study information

Scientific title

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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Nitrofurantoin

Primary outcome measures

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 trial start date

01/03/2004

Overall trial end date

01/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women with gestational age 12 - 32 weeks
2. Willing and able to give consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

900

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, Thailand, Viet Nam

Trial 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/

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

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes