The 3-Day Malarone Schedule: Acceptability and Tolerability for Malaria Prophylaxis in Adults Travelling to Malaria Endemic Areas.
The 3-Day Malarone Schedule: Acceptability and Tolerability for Malaria Prophylaxis in Adults Travelling to Malaria Endemic Areas
Colleen Lau
222 participants
Oct 25, 2016
Interventional
Conditions
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.
Eligibility
Inclusion Criteria7
- Over 18 years of age
- Travelling to a malaria-endemic area in Asia, Pacific Islands, and South/Central
- America for 4 weeks or less
- Able to give written Informed Consent and sign consent after all aspects of the
- protocol explained
- Subject must agree to participate in all planned follow-up telephone reviews, and to
- return their Memory Aid and Diary to their travel clinic.
Exclusion Criteria10
- Previous adverse reactions to Malarone
- 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).
- Pregnancy or planning pregnancy.
- Significant medical conditions including diabetes, heart problems, asthma, epilepsy,
- depression, renal impairment, gastrointestinal disorders, and those taking long-term
- antibiotics.
- Travelling to highly endemic countries with a high risk of malaria, e.g Sub-Saharan
- Africa.
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Interventions
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.
Locations(1)
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ACTRN12616000640404