AzTrials
AzTrials

MalariaPhase 3TRANSACT2NCT01939886

Treatment Efficacy and Malaria TRANSmission After Artemisinin Combination Therapy 2 (TRANSACT2)

A Phase 3 study testing Mefloquine - Artesunate and Artemether-lumefantrine combination in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the first line treatment policy in Kenya. AL is an efficacious drug that also has the capacity to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the development of parasite resistance against AL. Read more about this study

Who is it for?
Ages 6 months to 10 years
Conditions the study is for
Malaria
What is being tested?
Mefloquine - Artesunate and Artemether-lumefantrine combination
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
1 siteKenya
Study dates
Apr 2013to Nov 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 6 months - 10 years
  • Residents of research area (5 km around the clinic)
  • Willingness to come for complete scheduled follow-up.
  • Uncomplicated malaria with P. falciparum mono-infection
  • Parasitaemia of 1000-200,000 parasites/ul
  • Temperature > 37.5°C and < 39.5°C, or history of fever in previous 24 hours.
  • No history of adverse reactions to AL
  • Understanding of the procedures of the study by parent or guardian and willing to participate by signing informed consent forms.

Who cannot join

  • General signs of severe malaria
  • Haemoglobin concentration < 5g/dl
  • Presence of disease other than malaria causing febrile conditions
  • Mixed infection with P. malariae or other non-falciparum malaria species
  • Unwilling to participate and sign informed consent forms.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • St. Jude's Clinic, ICIPE Thomas Odhiambo Campus

    Mbita, Nyanza, 40305

Other trials in Kenya

About this study

Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the first line treatment policy in Kenya. AL is an efficacious drug that also has the capacity to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the development of parasite resistance against AL. Clinical trials in Asia showed that mefloquine-artesunate (MQ-AS) may be more efficacious than AL and may have a more pronounced beneficial effect on post-treatment malaria transmission. MQ-AS is registered and used in Kenya but there have been no reported direct comparisons of AL and MQ-AS with clinical and transmission endpoints (i.e. adequately clearing parasites and preventing transmission to mosquitoes).

Screening for molecular markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment malaria transmission can assist strategies to prevent the development and spread of ACT resistance.

Read more

In the current study, we compare AL and MQ-AS for the treatment of uncomplicated malaria. Our endpoints are i) clinical efficacy, ii) post-treatment gametocytaemia by molecular techniques.

In the current study, the investigators compare AL and MQ-AS for the treatment of uncomplicated malaria. The investigators endpoints are

clinical efficacy post-treatment gametocytaemia by molecular techniques

Read the detailed description

Accurate diagnosis followed by prompt and efficacious treatment is the backbone of any malaria control programme. However, malaria treatment has been facing huge challenges in recent years. A number of affordable antimalarial drugs have been used to cure malaria since the 1940s: these include chloroquine (CQ), sulphadoxine-pyrimethamine (SP; Fansidar®), mefloquine (MQ), amodiaquine (AQ) and quinine. The emergence and spread of resistance to these commonly-used drugs has been largely responsible for the worsening of the malaria situation observed in the past decades.

Across the African continent, guidelines have recently been changed. The World Health Organization (WHO) recommends for falciparum malaria the use of combination therapies, preferably those containing artemisinin derivatives (ACT, artemisinin-based combination therapy). Artemisinin derivatives, e.g. artesunate, artemether and dihydroartemisinin, being extremely potent antimalarial agents are the ideal partners in combinations with other antimalarials. ACTs have three demonstrable advantages over conventional therapy, they i) are efficacious in clearing asexual parasites, ii) substantially reduce post-treatment gametocyte carriage and iii) "protect" the partner drug from selecting resistant parasites.

In Kenya, both CQ and SP have lost clinical efficacy. CQ was replaced by SP in 1998 and in the year 2006, SP was effectively replaced by Artemether-Lumefantrine (AL: Coartem®). The policy change to the artemisinin-based drug AL is in line with the WHO recommendations to shift to ACT as first line antimalarial treatment.The most efficacious ACT, however, needs local comparisons in terms of treatment efficacy and transmission-reducing activity.

Conditions
Malaria
Being tested
Mefloquine - Artesunate, Artemether-lumefantrine combination
Keywords
Malaria treatment efficacy, Malaria transmission
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mefloquine - ArtesunateDrug

    Also called Artequin

  • Artemether-lumefantrine combinationDrug

    Also called Coartem

Study groups in NCT01939886
Study groupRoleWhat they receive
Artemether- LumefantrineExperimentalTreatment with artemether-lumefantrine (AL; Coartem; Novartis Pharma), administered as half a tablet (20 mg of artemether and 120 mg of lumefantrine) per 5 kg of body weight in a 6-dose regimen (at enrolment and 8, 20, 32, 44, and 56 h [+/-90 min] after the initiation of treatment). AL is currently the first line treatment in Tanzania Other Name: Coartem;
Receives: Drug: Artemether-lumefantrine combination
Drug: Mefloquine-Artesunate, an alternative ACTActive comparatorTreatment with the paediatric fixed dose combination Mefloquine-Artesunate (MQ-AS; Artequin; Mepha, Aesch, Basel, Switzerland, artesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, given in three daily doses. The weight range of enrolled children is chosen to be recommended for this fixed dose combination. MQ-AS is available in Kenya as Artequin and has been extensively tested in uncomplicated malaria in children.
Receives: Drug: Mefloquine - Artesunate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the number of participants with clinical and parasitological treatment failure after treatment artemether-lumefantrine (AL) and mefloquine-artesunate MQ-AS

    Parasite prevalence will be determined by microscopy and molecular methods on days 3-42 after intitiation of treatment. Clinical (fever+parasitological failure) and parasitological efficacy will be determined in relation to treatment arm and parasite clearance dynamics

    Measured: 42 day follow-up

Secondary outcomes (1)

  1. the number of individuals with gametocytes after treatment with AL or MQ-AS

    gametocyte carriage will be determined by microscopy and molecular QT-NASBA to generate gametocyte prevalence estimates on follow-up days and the mean duration of gametocyte carriage in days.

    Measured: 42 days follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01939886
Sponsor's protocol ID
TRANSACT 2
Acronym
TRANSACT2
Status last verified
Nov 2013
First submitted
3 Sep 2013
Last updated
28 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Beshir KB, Sutherland CJ, Sawa P, Drakeley CJ, Okell L, Mweresa CK, Omar SA, Shekalaghe SA, Kaur H, Ndaro A, Chilongola J, Schallig HD, Sauerwein RW, Hallett RL, Bousema T. Residual Plasmodium falciparum parasitemia in Kenyan children after artemisinin-combination therapy is associated with increased transmission to mosquitoes and parasite recurrence. J Infect Dis. 2013 Dec 15;208(12):2017-24. doi: 10.1093/infdis/jit431. Epub 2013 Aug 14.

    PubMed 23945376

  • Sawa P, Shekalaghe SA, Drakeley CJ, Sutherland CJ, Mweresa CK, Baidjoe AY, Manjurano A, Kavishe RA, Beshir KB, Yussuf RU, Omar SA, Hermsen CC, Okell L, Schallig HD, Sauerwein RW, Hallett RL, Bousema T. Malaria transmission after artemether-lumefantrine and dihydroartemisinin-piperaquine: a randomized trial. J Infect Dis. 2013 Jun 1;207(11):1637-45. doi: 10.1093/infdis/jit077. Epub 2013 Mar 6.

    PubMed 23468056

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mefloquine - Artesunate and Artemether-lumefantrine combination in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the number of participants with clinical and parasitological treatment failure after treatment artemether-lumefantrine (AL) and mefloquine-artesunate MQ-AS (time frame: 42 day follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01939886, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.

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