Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000442404
Ethics application status
Approved
Date submitted
21/08/2007
Date registered
31/08/2007
Date last updated
31/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of Azithromycin in pregnancy
Scientific title
Measurement of the pharmacokinetic parameters of Azithromycin in pregnant women to evaluate its potential use in preventing malaria in this population.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 2286 0
Condition category
Condition code
Infection 2379 2379 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Azihromycin 1.5g daily for two days in combination with with either:
1) Chloroquine 10mg/kg daily for three days -or-
2) Sulphadoxine/Pyrimethamine (SP) 25mg/1.25mg per kg as a single dose on the first day
Intervention code [1] 1998 0
Prevention
Comparator / control treatment
The pharmacokinetic disposition of azithromycin will be compared between the group that receives chloroquine and the group receiving sulpfadoxine/pyrimethamine.
Control group
Active

Outcomes
Primary outcome [1] 3277 0
Define the pharmacokinetic disposition of Azithromycin in Pregnancy
Timepoint [1] 3277 0
The amount of azithromycin will be measured from blood taken at 16 time points within a 2 week period. These are 1, 2, 3, 6, 9, 12, 18, 24, 32, 40, 48 hours during the first two days, then again at 3, 4, 5, 7,10 and 14 days.
Secondary outcome [1] 5459 0
Examine whether drug-interactions may affect pharmacokinetic disposition when chloroquine or SP are co-administered with azithromycin.
Timepoint [1] 5459 0
The amount of azithromycin will be measured from blood taken at 16 time points within a 2 week period. These are 1, 2, 3, 6, 9, 12, 18, 24, 32, 40, 48 hours during the first two days, then again at 3, 4, 5, 7,10 and 14 days.
Secondary outcome [2] 5460 0
To generate preliminary data on treatment efficacy of azithromycin-chloroquine and azithromycin-SP in pregnant women in Papua New Guinea (PNG).
Timepoint [2] 5460 0
Reappearance of parasitemia or Polymerase Chain Reaction (PCR) positivity over the 42-day monitoring period

Eligibility
Key inclusion criteria
Pregnancy
Melanesian
Minimum age
N/A
Maximum age
N/A
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe malaria
Severe anaemia
Pregnancy associated complications

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 565 0
Papua New Guinea
State/province [1] 565 0

Funding & Sponsors
Funding source category [1] 2537 0
Government body
Name [1] 2537 0
National Health and Medical Research Council
Country [1] 2537 0
Australia
Primary sponsor type
Individual
Name
Professor Tim M.E. Davis
Address
University of Western Australia
School of Medicine and Pharmacology
Fremantle Hospital
P.O. Box 480 Fremantle
Western Australia 6959
Country
Australia
Secondary sponsor category [1] 2295 0
Individual
Name [1] 2295 0
Dr Ivo Muller
Address [1] 2295 0
PO BOX 60,
Goroka, EHP 411
Country [1] 2295 0
Papua New Guinea

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4455 0
Ethics committee address [1] 4455 0
Ethics committee country [1] 4455 0
Date submitted for ethics approval [1] 4455 0
12/07/2007
Approval date [1] 4455 0
Ethics approval number [1] 4455 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27998 0
Address 27998 0
Country 27998 0
Phone 27998 0
Fax 27998 0
Email 27998 0
Contact person for public queries
Name 11155 0
Professor Tim Davis
Address 11155 0
University of Western Australia
School of Medicine and Pharmacology
Fremantle Hospital
P.O. Box 480 Fremantle
Western Australia 6959
Country 11155 0
Australia
Phone 11155 0
9431 3229
Fax 11155 0
Email 11155 0
[email protected]
Contact person for scientific queries
Name 2083 0
Professor Tim Davis
Address 2083 0
University of Western Australia
School of Medicine and Pharmacology
Fremantle Hospital
P.O. Box 480 Fremantle
Western Australia 6959
Country 2083 0
Australia
Phone 2083 0
9431 3229
Fax 2083 0
Email 2083 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.