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
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 34 69 |
|---|---|
| ringwaldp@who.int |
Study information
| Study design | One-arm surveillance study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To 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) studied | Malaria |
| Intervention | Each 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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artesunate, sulfadoxine-pyrimethamine, artemether-lumefantrine |
| Primary outcome measure | Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected. |
| Secondary outcome measures | Incidence of adverse events. |
| Overall study start date | 01/08/2007 |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 180 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/08/2007 |
| Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- Sudan
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO)/HIV/AIDS, Tuberculosis and Malaria (HTM) - Global Malaria Programme
Research organisation
Research organisation
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int/malaria/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Sudan)
Private sector organisation / International organizations
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
