MalariaIPTc/ITNsNCT00738946
A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
A study testing Intermittent preventive treatment with AQ+ SP in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up… Read more about this study
- Who is it for?
- Ages 3 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Intermittent preventive treatment with AQ+ SP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Permanent residence in the study area with no intention of leaving during the surveillance period.
- Obtention of informed consent.
Who cannot join
- Temporary residence in the study area.
- Absence of informed consent.
- Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
- A history of a previous, significant adverse reaction to either of the study drugs.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Burkina Faso1 site
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Kadiogo, BP 2208
About this study
An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.
Read the detailed description
The trial will be conducted in 6000 children in Burkina Faso and Mali in 2008 and 2009. Each site will enroll 3,000 children. All children will be allocated a long lasting insecticide-treated net and randomized to receive to treatment (amodiaquine + sulfadoxine-pyrimethamine (AQ+SP)) or placebo (AQ-placebo + SP-placebo. Treatment will be administered over 3 rounds during the high malaria transmission season, with one month interval between rounds. Full course treatment of AQ and SP will be administered on each occasion. Treatment will not be given in the second year. Passive surveillance of malaria will be implemented for the monitoring of malaria morbidity and to assess whether children who received intermittent preventive treatment (IPT) are at increased risk of malaria. Adverse events will be monitored during each round of IPT administration. To assess the effect of IPTc on the prevalence of malaria infection, a random sample of 150 children will be visited every week during the high malaria transmission period. This number will be increased to 300 during the low transmission season, but the survey will be reduced to monthly visits. Baseline prevalence of genetic markers of resistance to SP and AQ will be estimated. A second cross-sectional survey will be conducted at the end of the malaria transmission season to assess the effect of IPT on the prevalence of genetic markers of resistance to SP and AQ, on the prevalence of anaemia and on nutritional indicators.
- Conditions
- Malaria
- Being tested
- Intermittent preventive treatment with AQ+ SP
- Keywords
- Intermittent Preventive treatment, insecticide treated bednets, malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent preventive treatment with AQ+ SPDrug
Also called IPTc
Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Amodiaquine+pyrimethamine versus placebo Receives: Drug: Intermittent preventive treatment with AQ+ SP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical malaria
Measured: 2008-2009
Secondary outcomes (1)
Incidence of severe malaria, Incidence of anemia, Prevalence of anemia, Prevalence of parasitemia, Proportion of children with parasites carrying resistance markers to AQ and SP, Incidence of hospital admissions due to malaria.
Measured: 2008-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre national de recherche et de formation sur le paludisme, Malaria Research and Training Center, Bamako, Mali
- Investigators
- Brian M Greenwood, MD, FRCP, Study director, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738946
- Sponsor's protocol ID
- IPTCVP17
- Acronym
- IPTc/ITNs
- Status last verified
- Jun 2010
- First submitted
- 20 Aug 2008
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Konate AT, Yaro JB, Ouedraogo AZ, Diarra A, Gansane A, Soulama I, Kangoye DT, Kabore Y, Ouedraogo E, Ouedraogo A, Tiono AB, Ouedraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood BM, Diallo DA. Morbidity from malaria in children in the year after they had received intermittent preventive treatment of malaria: a randomised trial. PLoS One. 2011;6(8):e23391. doi: 10.1371/journal.pone.0023391. Epub 2011 Aug 12.
PubMed 21858097Dicko A, Barry A, Dicko M, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Conare T, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Malaria morbidity in children in the year after they had received intermittent preventive treatment of malaria in Mali: a randomized control trial. PLoS One. 2011;6(8):e23390. doi: 10.1371/journal.pone.0023390. Epub 2011 Aug 12.
PubMed 21858096Konate AT, Yaro JB, Ouedraogo AZ, Diarra A, Gansane A, Soulama I, Kangoye DT, Kabore Y, Ouedraogo E, Ouedraogo A, Tiono AB, Ouedraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood B, Diallo DA. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Burkina Faso: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000408. doi: 10.1371/journal.pmed.1000408.
PubMed 21304925Dicko A, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Diawara H, Conare T, Djimde A, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Mali: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000407. doi: 10.1371/journal.pmed.1000407.
PubMed 21304923
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
- ClinicalTrials.gov ID
- NCT00738946
- Acronym / sponsor ID
- IPTc/ITNs / IPTCVP17
- Conditions
- Malaria
- Keywords
- Intermittent Preventive treatment, insecticide treated bednets, malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Centre national de recherche et de formation sur le paludisme, Malaria Research and Training Center, Bamako, Mali
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.
Detailed description
The trial will be conducted in 6000 children in Burkina Faso and Mali in 2008 and 2009. Each site will enroll 3,000 children. All children will be allocated a long lasting insecticide-treated net and randomized to receive to treatment (amodiaquine + sulfadoxine-pyrimethamine (AQ+SP)) or placebo (AQ-placebo + SP-placebo. Treatment will be administered over 3 rounds during the high malaria transmission season, with one month interval between rounds. Full course treatment of AQ and SP will be administered on each occasion. Treatment will not be given in the second year. Passive surveillance of malaria will be implemented for the monitoring of malaria morbidity and to assess whether children who received intermittent preventive treatment (IPT) are at increased risk of malaria. Adverse events will be monitored during each round of IPT administration. To assess the effect of IPTc on the prevalence of malaria infection, a random sample of 150 children will be visited every week during the high malaria transmission period. This number will be increased to 300 during the low transmission season, but the survey will be reduced to monthly visits. Baseline prevalence of genetic markers of resistance to SP and AQ will be estimated. A second cross-sectional survey will be conducted at the end of the malaria transmission season to assess the effect of IPT on the prevalence of genetic markers of resistance to SP and AQ, on the prevalence of anaemia and on nutritional indicators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Intermittent preventive treatment with AQ+ SPAmodiaquine+pyrimethamine versus placebo |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Permanent residence in the study area with no intention of leaving during the surveillance period.
- Obtention of informed consent.
Key exclusion criteria (4 listed)
- Temporary residence in the study area.
- Absence of informed consent.
- Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
- A history of a previous, significant adverse reaction to either of the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent preventive treatment with AQ+ SPAlso: IPTcAmodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval | Drug | 2 |
Primary outcome
Incidence of clinical malaria
Time frame: 2008-2009
1 secondary outcome
Incidence of severe malaria, Incidence of anemia, Prevalence of anemia, Prevalence of parasitemia, Proportion of children with parasites carrying resistance markers to AQ and SP, Incidence of hospital admissions due to malaria.
Time frame: 2008-2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
- Derived from this study: PubMed 21858097Konate AT, Yaro JB, Ouedraogo AZ, Diarra A, Gansane A, Soulama I, Kangoye DT, Kabore Y, Ouedraogo E, Ouedraogo A, Tiono AB, Ouedraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood BM, Diallo DA. Morbidity from malaria in children in the year after they had received intermittent preventive treatment of malaria: a randomised trial. PLoS One. 2011;6(8):e23391. doi: 10.1371/journal.pone.0023391. Epub 2011 Aug 12.
- Derived from this study: PubMed 21858096Dicko A, Barry A, Dicko M, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Conare T, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Malaria morbidity in children in the year after they had received intermittent preventive treatment of malaria in Mali: a randomized control trial. PLoS One. 2011;6(8):e23390. doi: 10.1371/journal.pone.0023390. Epub 2011 Aug 12.
- Derived from this study: PubMed 21304925Konate AT, Yaro JB, Ouedraogo AZ, Diarra A, Gansane A, Soulama I, Kangoye DT, Kabore Y, Ouedraogo E, Ouedraogo A, Tiono AB, Ouedraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood B, Diallo DA. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Burkina Faso: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000408. doi: 10.1371/journal.pmed.1000408.
- Derived from this study: PubMed 21304923Dicko A, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Diawara H, Conare T, Djimde A, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Mali: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000407. doi: 10.1371/journal.pmed.1000407.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian M Greenwood, MD, FRCP study director
London School of Hygiene and Tropical Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent preventive treatment with AQ+ SP in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical malaria (time frame: 2008-2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738946, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.