Contact information
Type
Scientific
Primary contact
Prof Jim Neilson
ORCID ID
Contact details
School of Reproductive and Developmental Medicine
University of Liverpool
1st floor
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
+44 (0)151 702 4100
jneilson@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
065810/Z/01/Z
Study information
Scientific title
A randomised, community-based trial of Azithromycin for the Prevention of Pre-term Labour in Malawi
Acronym
APPLe
Study hypothesis
That routine antibiotic prophylaxis in a pregnant population with high burdens of infection, and high incidence of preterm birth, would reduce the incidence of prematurity.
Ethics approval
College Of Medicine Research Ethics Committee (COMREC), Blantyre (Malawi) approved in November 2003
Study design
Four centre placebo-controlled, randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Preterm birth
Intervention
Azithromycin 1 g orally or placebo at 16 - 24 weeks and 28 - 32 weeks. For main trial, follow-up was to 6 weeks after birth. Children have been followed up to 18 months of age.
Intervention type
Drug
Phase
Not Applicable
Drug names
Azithromycin
Primary outcome measures
Preterm birth (less than 37 weeks gestation).
Secondary outcome measures
1. Mean gestational age at birth
2. Perinatal mortality
3. Birthweight
4. Malarial parasites at 28 - 32 weeks
5. Haemoglobin at 28 - 32 weeks
Overall trial start date
01/02/2004
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pregnant women less than 24 weeks gestational age by ultrasound at recruitment
2. No age restriction, apart from age being compatible with pregnancy
3. Intention to remain within the district throughout pregnancy
4. Informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2300
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/02/2004
Recruitment end date
31/07/2007
Locations
Countries of recruitment
Malawi
Trial participating centre
School of Reproductive and Developmental Medicine
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
University of Liverpool (UK)
Sponsor details
Brownlow Hill
Liverpool
L69 3BX
United Kingdom
jdowson@liv.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 065810)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer Inc. (USA) - supplied drug and placebo
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19956761
Publication citations
-
Results
van den Broek NR, White SA, Goodall M, Ntonya C, Kayira E, Kafulafula G, Neilson JP, The APPLe study: a randomized, community-based, placebo-controlled trial of azithromycin for the prevention of preterm birth, with meta-analysis., PLoS Med., 2009, 6, 12, e1000191, doi: 10.1371/journal.pmed.1000191.