ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000640404

Ethics application status

Approved

Date submitted

10/05/2016

Date registered

17/05/2016

Date last updated

4/06/2019

Date data sharing statement initially provided

18/03/2019

Date results provided

18/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The 3-Day Malarone Schedule: Acceptability and Tolerability for Malaria Prophylaxis in Adults Travelling to Malaria Endemic Areas.

Scientific title

The 3-Day Malarone Schedule: Acceptability and Tolerability for Malaria Prophylaxis in Adults Travelling to Malaria Endemic Areas

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Malaria

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The trial will assess the use of a 3-day schedule of Atovaquone-Proguanil (250/100mg per tablet) for malaria prophylaxis. The modified schedule involves taking 4 tablets per day for 3 consecutive days to provide protection for one month. The 3-day schedule will be completed at least 2-5 days prior to leaving Australia, depending on duration of travel, itinerary, and convenience. A travel medicine nurse will contact the traveller by phone prior to departure from Australia to monitor adherence to the recommended schedule. If a traveller is unable to tolerate the 3-day schedule, alternative malaria chemoprophylaxis will be arranged prior to departure.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Tolerability of the 3-day schedule of Atovaquone-Proguanil for malaria prophylaxis. Tolerability will be assessed using a memory aid and symptom diary (4-point Likert Scale) to record the frequency and severity of adverse events.

Timepoint [1]

One week after travellers return from overseas travel to malaria-endemic area.

Primary outcome [2]

Acceptability of the 3-day schedule of Atovaquone-Proguanil for malaria prophylaxis. Acceptability will be assessed during post-travel telephone interviews to be conducted by travel health nurses. Travellers will be asked if they would choose to take the 3-day Malarone schedule again if travelling to another malaria endemic area in the future, and the reasons for their decision including considerations related to convenience and cost.

Timepoint [2]

One week after travellers return from overseas travel to malaria-endemic area.

Primary outcome [3]

Compliance with the 3-day schedule of Atovaquone-Proguanil for malaria prophylaxis. Compliance will be assessed during pre-travel telephone interviews to be conducted by travel health nurses. Nurses will call each traveller prior to departure to ask whether the 3-day schedule of tablets had been taken properly. If not, the reasons for non-compliance will be ascertained. If travellers were unable to complete the 3-day schedule because of adverse events, alternative chemoprophylaxis will be arranged prior to travel.

Timepoint [3]

One week after travellers return from overseas travel to malaria-endemic area.

Secondary outcome [1]

Prevalence of adverse events from 3-day schedule of Malarone. The most common adverse events include nausea, vomiting, abdominal pain, diarrhoea, headache, and mouth ulcers. Adverse events will be assessed using a 4-point Likert Scale in a symptom diary.

Timepoint [1]

One week after travellers return from overseas travel to malaria-endemic area.

Eligibility

Key inclusion criteria

1. Over 18 years of age
2. Travelling to a malaria-endemic area in Asia, Pacific Islands, and South/Central
America for 4 weeks or less
3. Able to give written Informed Consent and sign consent after all aspects of the
protocol explained
4. Subject must agree to participate in all planned follow-up telephone reviews, and to
return their Memory Aid and Diary to their travel clinic.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Previous adverse reactions to Malarone
2. Taking other medications that adversely interact with Malarone (metoclopramide,
rifampicin and tetracyclines may decrease the efficacy of Atovaquone; fluvoxamine may
decrease the efficacy of Proguanil).
3. Pregnancy or planning pregnancy.
4. Significant medical conditions including diabetes, heart problems, asthma, epilepsy,
depression, renal impairment, gastrointestinal disorders, and those taking long-term
antibiotics.
5. Travelling to highly endemic countries with a high risk of malaria, e.g Sub-Saharan
Africa.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised 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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Phase 3 / Phase 4

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2016

Actual

25/10/2016

Date of last participant enrolment

Anticipated

Actual

1/03/2018

Date of last data collection

Anticipated

31/05/2018

Actual

31/05/2018

Sample size

Target

222

Accrual to date

Final

232

Recruitment in Australia

Recruitment state(s)

QLD,SA,WA

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

N/A

Country [1]

Primary sponsor type

Individual

Name

Colleen Lau

Address

Department of Global Health
Research School of Population Health
Australian National University,
Building 62, Mills Road
Canberra, ACT 0200

Postal address:
Dr Colleen Lau
P O Box 2726,
New Farm, QLD 4005

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Deborah Mills

Address [1]

Dr Deb The Travel Doctor
5th Floor, 247 Adelaide St,
Brisbane, QLD 4000

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Ms Lani Ramsay

Address [1]

Travel-Bug Vaccination Clinic
182 Ward St
Adelaide, SA 5006

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Andrew Ebringer

Address [2]

Senior Medical Director
International SOS
Level 27, 288 Edward St
Brisbane, QLD 4000

Country [2]

Australia

Other collaborator category [3]

Other

Name [3]

Travel Medicine Centre Perth

Address [3]

Ground Floor, 5 Mill St,
Perth WA 6000

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, Australian National University

Ethics committee address [1]

Research Integrity & Compliance,
Research Services,
Ground Floor, Chancelry 10B
Ellery Crescent,
The Australian National University
ACTON ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/05/2016

Approval date [1]

25/08/2016

Ethics approval number [1]

2016087

Summary

Brief summary

Malaria is one of the most common causes of fever in Australian travellers, with approximately 400 cases reported each year in Australia. In addition, some travellers develop malaria and seek treatment while overseas, and are not included in these reported numbers. Most travellers who develop malaria did not take anti-malarial medications, or did not take the medications properly (e.g. forgot to take tablets). Malaria is a serious illness, and could potentially be life-threatening if not treated promptly. Antimalarial medications reduce the risk of malaria by about 90%, and the most commonly used options in Australia are Malarone, Doxycycline, and Mefloquine (Lariam). This research project aims to reduce the risk of malaria in travellers by improving compliance with anti-malarial medications. We propose to test the acceptability and tolerability of a 3-day schedule of a malaria medication called Malarone. Currently, travellers are required to take Malarone daily, starting 2 days before travel to a malaria risk area and continuing until 7 days after leaving the area. With the 3-day schedule, travellers will only need to take medications for 3 days and be protected for 4 weeks. The schedule will likely improve compliance and therefore reduce the risk of malaria. For trips that are of 4 weeks duration or less, travellers will be able to complete their antimalarial medications before leaving home, and not worry about carrying or taking tablets during their trip.

Trial website

Trial related presentations / publications

Public notes

The Malarone tablets will be paid for by each individual traveller (or their employer for work-related trips), just as travellers would normally pay for any malaria chemoprophylaxis.  This study has not received funding for medications from the clinics, doctors, researchers, pharmaceutical companies, or any other third parties.

Attachments [1]

/AnzctrAttachments/370664-2016087_Lau_Study Protocol_3MT.pdf

Contacts

Principal investigator

Name

Dr Colleen Lau

Address

Department of Global Health
Research School of Population Health
Australian National University
Building 62, Mills Road
Canberra, ACT 0200

Country

Australia

Phone

+61 402134878

Fax

colleen.lau@anu.edu.au

Contact person for public queries

Name

Colleen Lau

Address

Department of Global Health
Research School of Population Health
Australian National University
Building 62, Mills Road
Canberra, ACT 0200

Country

Australia

Phone

+61 402134878

Fax

colleen.lau@anu.edu.au

Contact person for scientific queries

Name

Colleen Lau

Address

Department of Global Health
Research School of Population Health
Australian National University
Building 62, Mills Road
Canberra, ACT 0200

Country

Australia

Phone

+61 402134878

Fax

colleen.lau@anu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Confidentiality

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

Source	Title	Year of Publication	DOI
Embase	Drug-free holidays: Compliance, tolerability, and acceptability of a 3-day atovaquone/proguanil schedule for pretravel malaria chemoprophylaxis in australian travelers.	2019	https://dx.doi.org/10.1093/cid/ciy854

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically