ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000696099

Ethics application status

Approved

Date submitted

19/05/2010

Date registered

24/08/2010

Date last updated

3/03/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in At Tur Bani Qa'is, Harad, Almusaymir, Jabal Ash Sharq, Al Udayn and Bajil districts in Yemen

Scientific title

Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Yemen

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

Studies of infection and infectious agents

Public Health

Epidemiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

One-arm propective evaluation with:
(a) artesunate+sulfadoxine/pyrimethamine combination therapy in 4 sites (Al Tor beni Qais, Harad, Almosaimeer, Al Odein) and
(b) artemether-lumefantrine combination therapy in two sites (Jabal Al Sharq and Bajil).

Dose regimen:
(a) artesunate+sulfadoxine/pyrimethamine tablets: artesunate 4 mg/kg body weight (bw) per day for 3 days plus a single dose of 25/1.25 mg/kg bw of sulfadoxine/ pyrimethamine.

(b) artemether-lumefantrine tablets (tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrine twice a day for 3 days according to the following weigth bands:
5-14 kg bw: 1 tablet; 15-24 kg bw: 2 tablets; 25-34 kg bw: 3 tablets and =35 kg bw: 4 tablets.

All treatment will be orally taken tablets

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

% of artesunate+sulfadoxine/pyrimethamine treatment failure (early treatment failure+late clinical failure+late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).

Timepoint [1]

At 28 day following treatment

Primary outcome [2]

% of artemether-lumefantrine treatment failure (early treatment failure+late clinical failure+late parasitological failure).
Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).

Timepoint [2]

At 28 day following treatment

Primary outcome [3]

% of adverse events in the artesunate+sulfadoxine/ pyrimethamine and artemether-lumefantrine treated groups.

All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the case report form.

Timepoint [3]

At 28 day following treatment

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

1. age 6 months and above;
2. mono-infection with Plasmodium falciparum (P.falciparum) detected by microscopy;
3. parasitaemia of 500-200000/microliter asexual forms;
4. presence of axillary temperature less than or equal to 37.5 degrees centigrade;
5. ability to swallow oral medication;
6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
7. informed consent from the patient or from a parent or guardian in the case of children.

Minimum age

6 Months

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization (WHO).
2. mixed or mono-infection with another Plasmodium species detected by microscopy;
3. presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference <110 mm);
4. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human immunodeficiency virus/Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (HIV/AIDS);
5. regular medication, which may interfere with antimalarial pharmacokinetics;
6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
7. unmarried women of child-bearing age;
8. a positive pregnancy test or breastfeeding;
9. unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age.

Study design

Purpose of the study

Treatment

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 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/11/2009

Actual

8/11/2009

Date of last participant enrolment

Anticipated

Actual

3/02/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

522

Accrual to date

Final

Recruitment outside Australia

Country [1]

Yemen

State/province [1]

Hajja Governorate

Country [2]

Yemen

State/province [2]

Al-Hudeida Governorate

Country [3]

Yemen

State/province [3]

Ibb Governorate

Country [4]

Yemen

State/province [4]

Dhamar Governorate

Country [5]

Yemen

State/province [5]

Lahj Governorate

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ministry of Public Health and population

Address [1]

P.O. Box: 16544, Sana'a

Country [1]

Yemen

Primary sponsor type

Government body

Name

Ministry of Public Health and Population

Address

P.O. Box: 16544, Sana'a

Country

Yemen

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

World Health organization

Address [1]

20 Av. Appia, 1211 Geneva 27 Switzerland

Country [1]

Switzerland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

General Doctorate for Research and Studies

Ethics committee address [1]

P.O. Box: 16544, Sana'a

Ethics committee country [1]

Yemen

Date submitted for ethics approval [1]

Approval date [1]

12/10/2009

Ethics approval number [1]

Ethics committee name [2]

WHO Ethical Review Committee (ERC)

Ethics committee address [2]

20 Av. Appia, 
1211 Geneva 27 Switzerland

Ethics committee country [2]

Switzerland

Date submitted for ethics approval [2]

11/12/2009

Approval date [2]

21/01/2010

Ethics approval number [2]

RPC372

Summary

Brief summary

The study assesses the efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in The participants will be febrile patients aged 6 months and above with confirmed uncomplicated P. falciparum infection. Artesunate (4mg/kg over 3 days) co-administered with sulfadoxine/pyrimethamine (single dose of 25mg sulfadoxine/1.25mg pyrimethamine per kg on day 0) will be tested in four of the sites and artemether-lumefantrine (a 6-dose regimen of artemether-lumefantrine twice a day for 3 days) in the other two sites. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from November 2009 to April 2010.

Trial website

Trial related presentations / publications

The data from the study was communicated to Ministry of health. No peer reviewed publication has been published yet.

Public notes

Contacts

Principal investigator

Name

Dr Fathi Ali Mohammed Hizam

Address

National Malaria Control Programme,
Ministry of Public Health & Population
PO Box: 16544, Sana'a, Yemen.
Sana'a
Yemen

Country

Yemen

Phone

+967 1626107

Fax

[email protected]

Contact person for public queries

Name

Dr Mohamed Abdullah Al-Henemi

Address

National Malaria Control Programme, P.O. Box: 16544, Sana'a

Country

Yemen

Phone

+9671626107

Fax

[email protected]

Contact person for scientific queries

Name

Dr Fathi Ali Mohammed Hizam

Address

National Malaria Control Programme, P.O. Box: 16544, Sana'a

Country

Yemen

Phone

+967 1626107

Fax

[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

Source	Title	Year of Publication	DOI
Embase	High efficacy of two artemisinin-based combinations: Artesunate + sulfadoxine-pyrimethamine and artemether-lumefantrine for falciparum malaria in Yemen.	2015	https://dx.doi.org/10.1186/s12936-015-0970-2

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

Trial Review

Documents added manually

Documents added automatically