Efficacy and safety of artesunate and sulfadoxine-pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in low to moderate sentinel sites in Sudan

ISRCTN ISRCTN45665690
DOI https://doi.org/10.1186/ISRCTN45665690
Secondary identifying numbers RPC220
Submission date
14/08/2007
Registration date
15/08/2007
Last edited
11/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pascal Ringwald
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone +41 (0)22 791 34 69
Email ringwaldp@who.int

Study information

Study designOne-arm surveillance study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo assess the efficacy of the first (artesunate and sulfadoxine-pyrimethamine) and second line treatment (artemether-lumefantrine) for the treatment of uncomplicated Plasmodium falciparum infections in different sentinel sites in Sudan.
Ethics approval(s)Ethics approval received from:
1. Federal Ministry of Health (Sudan) on the 3rd May 2007
2. Ethical Research Committee of the World Health Organization (WHO) on the 11th June 2007 (ref: RPC220)
Health condition(s) or problem(s) studiedMalaria
InterventionEach patient will receive both:
1. Artemether-lumefantrine six consecutive doses according to manufacturer recommendation over three days orally (per os)
2. Artesunate 12 mg/kg over three days per os and sulfadoxine-pyrimethamine 1/2 tablet 500 mg - 25 mg/10 kg single dose per os

Principal Investigator:
Dr Khalid A. Elmardi
National Malaria Control Programme
Federal Ministry of Health
P.O. Box 1204
Khartoum
Sudan
Tel: +249 (0)183 776809
Fax: +249 (0)183 770397
Email: khalidmrd9@hotmail.com
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Artesunate, sulfadoxine-pyrimethamine, artemether-lumefantrine
Primary outcome measureAdequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected.
Secondary outcome measuresIncidence of adverse events.
Overall study start date01/08/2007
Completion date30/11/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants180
Key inclusion criteria1. Aged over 6 months old
2. Infection with P. falciparum
3. Parasitaemia, 1000 - 100 000 asexual forms per µl
4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C
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
7. Informed consent from the patient or from a parent or guardian in case of children
Key exclusion criteria1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions
2. Mixed or mono-infection with another Plasmodium species
3. Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or who has symmetrical oedema involving at least the feet)
4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases
5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
6. Pregnancy or lactation
Date of first enrolment01/08/2007
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • Sudan
  • Switzerland

Study participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

World Health Organization (WHO)/HIV/AIDS, Tuberculosis and Malaria (HTM) - Global Malaria Programme
Research organisation

20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website http://www.who.int/malaria/
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO) (Sudan)
Private sector organisation / International organizations
Alternative name(s)
منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan