Efficacy and safety of artesunate and sulfadoxine-pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of vivax malaria in Nangarhar, Takhar and Faryab provinces, Afghanistan
| ISRCTN | ISRCTN40223079 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40223079 |
| Secondary identifying numbers | RPC243 |
- Submission date
- 15/11/2007
- Registration date
- 15/11/2007
- Last edited
- 15/11/2007
- 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
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3469 |
|---|---|
| ringwaldp@who.int |
Study information
| Study design | One arm non-comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Monitor efficacy and safety of artesunate and sulfadoxine-pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of vivax malaria. |
| Ethics approval(s) | Ethics approval received from: 1. Ministry of Public Health Afghanistan on the 15th September 2007 2. World Health Organization (WHO) Ethics Review Committee (ERC) on the 13th November 2007 (ref: RPC 243) |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | 1. Artesunate (12 mg/kg) and sulfadoxine (25 mg/kg single dose) - pyrimethamine (1.25 mg/kg single dose) over 3 days for falciparum malaria 2. Chloroquine 25 mg/kg over 3 days for vivax malaria Contact details for Principal Investigator: Dr Ghulam Rahim Awab District/Phase - 4 Jalalabad City Nangarhar Afghanistan Tel: +93 (0)70 004 4853 Email: awabgr@yahoo.com |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artesunate, sulfadoxine-pyrimethamine, chloroquine |
| Primary outcome measure | 1. To measure the clinical and parasitological efficacy of artesunate and sulfadoxine-pyrimethamine among patients aged above six months suffering from uncomplicated falciparum malaria and chloroquine for vivax malaria, by determining the proportion of patients with: 1.1. Early Treatment Failure (ETF) 1.2. Late Clinical Failure (LTF) 1.3. Late Parasitological Failure (LPF) 1.4. Adequate Clinical and Parasitological Response (ACPR) As indicators of efficacy 2. To differentiate recrudescences from new infections by the Polymerase Chain Reaction (PCR) analysis 3. To evaluate the incidence of adverse events |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 15/11/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Age above 6 months 2. Mono-infection with P. falciparum or P. vivax 3. Parasitaemia, 1000 - 100,000 asexual forms per µl for falciparum malaria and above 250 asexual forms per µl for vivax malaria 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 (see Annex 1) 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 less than 70% of the median of the National Center for Health Statistics [NCHS]/WHO normalised reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] less than 110 mm) 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 (e.g. cardiac, renal, hepatic diseases, Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrome [AIDS]) 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment 6. Positive pregnancy test or lactating (if adults included) |
| Date of first enrolment | 15/11/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Afghanistan
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3469 |
|---|---|
| ringwaldp@who.int | |
| Website | http://www.who.int/malaria/ |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland)
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 |
