Intermittent Preventive Therapy Post-Discharge: an innovative approach in the prevention of rebound severe malaria anaemia and mortality in young children
| ISRCTN | ISRCTN89727873 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89727873 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/05/2006
- Registration date
- 19/06/2006
- Last edited
- 10/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Feiko ter Kuile
Scientific
Scientific
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)151 7053287 |
|---|---|
| terkuile@liverpool.ac.uk |
Study information
| Study design | Randomised, double-blind, placebo-controlled, multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Intermittent Preventive Therapy Post-Discharge: an innovative approach in the prevention of rebound severe malaria anaemia and mortality in young children - a randomised double-blind placebo controlled multicentre study |
| Study acronym | IPTpd |
| Study objectives | To compare the efficacy of a single treatment course with lumefantrine-artemether (Coartem®) at discharge to three treatment courses with Coartem® given at discharge, 1 and 2 months (intermittent preventive therapy post-discharge [IPTpd]), to standard antimalarial therapy of oral sulfadoxine-pyrimethamine (SP) in Malawi, in the post-discharge management of children, aged 4-59 months, who have recovered from severe malarial anaemia by assessing mean haemoglobin concentration, and the incidence of rebound severe anaemia, clinical malaria and death by 3 and 6 months. As of 22/04/2010 this record was updated; all changes can be found in the relevant fields with the above update date. At this time, the anticipated end date of this trial was also updated; the initial anticipated end date at the time of registration was 01/12/2008. |
| Ethics approval(s) | Approved by College of Medicine Research and Ethics Committee on 25/02/05, reference number: P.03/04/287 and by Liverpool Research and Ethics Committee on 09/02/05, reference number: 05.01 |
| Health condition(s) or problem(s) studied | Severe malarial anaemia |
| Intervention | Patients are randomised into one of the following groups: Group A - lumefantrine-artemether, single 3-day course at enrolment Group B - lumefantrine-artemether, three 3-day courses (at enrolment, at 1 month, and at 2 months) Group C - sulfadoxine-pyrimethamine (SP), single dose at enrolment (added 22/04/2010: group C dropped out following amendments to protocol) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | lumefantrine-artemether (Coartem®), sulfadoxine-pyrimethamine |
| Primary outcome measure | Current information as of 22/04/2010: The incidence of rebound severe anaemia (Hb less than 5 g/L), severe malaria (hospital admissions requiring quinine) or death (a composite endpoint) between 1 and 6 months after enrolment. Initial information at time of registration: Mean haemoglobin at three months |
| Secondary outcome measures | Current information as of 22/04/2010: 1. The incidence of sick-child's clinic visits due to clinical malaria by 3 and 6 months 2. The incidence of all-cause sick-child's clinic visits by 3 and 6 months 3. The incidence of all cause re-hospitalisation between 1 - 3 and 1 - 6 months after enrolment 4. The incidence of the three individual components of the composite endpoint (severe anaemia, severe malaria, death) between 1 - 3 and 1 - 6 months after enrolment 5. Mean haemoglobin at 6 months 6. Incidence of adverse events by 3 and 6 months 7. Mean corrected heart rate (QTc) prolongation by 3 days Initial information at time of registration: 1. The incidence of sick-child's clinic visits due to clinical malaria by 3 and 6 months 2. The incidence of rebound severe anaemia (Hb <5 g/l) 3. The incidence of death by 3 and 6 months 4. Mean haemoglobin at 6 months 5. Incidence of adverse events by 3 and 6 months 6. Mean corrected heart rate (QTc) prolongation by 3 days |
| Overall study start date | 22/05/2006 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 1280 (initial). As of 22/04/2010: 1650 participants or 126 events |
| Key inclusion criteria | 1. Haemoglobin <5.0 g/dl or packed cell volume (PCV) <15% on admission to the hospital 2. Plasmodium falciparum malaria (any documented parasitaemia) at the time of admission to the hospital or within 24 hours prior to admission 3. Aged between 4 months (inclusive) and 59 months (inclusive) at the time of randomization 4. Bodyweight >5 kg at the time of randomization 5. Subject completed blood transfusion(s) in accordance with routine hospital practice 6. Subject completed intravenous (IV) quinine in accordance with routine hospital practice 7. Able to feed (for breastfed children) or eat (for older children) 8. Able to sit unaided 9. Provision of informed consent by parent or guardian |
| Key exclusion criteria | 1. Recognised, specific other cause of severe anaemia at the time of admission to the hospital (e.g. trauma, haematological malignancy, known bleeding disorder, known sickle cell disease) 2. Previous enrolment in the present study 3. Severe anaemia (haemoglobin <5.0 g/dl ) at the time of randomization 4. Known hypersensitivity to any of the study drugs 5. Documented intake of Coartem® (≥4 doses) or SP within 1 week prior to admission 6. Child resides outside of catchment area during the course of the study (6 months) 7. Known need at the time of randomization for concomitant prohibited medication during the 2 months randomized treatment period 8. Ongoing participation into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months) 9. Known need, or scheduled surgery during the course of the study (6 months) 10. Suspected non-compliance with the follow-up schedule |
| Date of first enrolment | 22/05/2006 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- England
- Malawi
- United Kingdom
Study participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
L3 5QA
United Kingdom
Sponsor information
Liverpool School of Tropical Medicine (UK)
University/education
University/education
Pembroke Place
Liverpool
L3 5QA
England
United Kingdom
| Phone | +44 (0)151 7053281 |
|---|---|
| hemingway@liverpool.ac.uk | |
| Website | http://www.liverpool.ac.uk/lstm |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Research organisation
The Netherlands-African partnership for capacity development and clinical interventions against poverty-related diseases (NACCAP) (Netherlands) (ref: W 07.05.202.00)
No information available
UBS Optimus Foundation (Switzerland)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | Yes | No |
