Uncomplicated Falciparum MalariaPhase 2NCT00959517
Trial of Artesunate Combination Therapy in Pakistan
A Phase 2 study testing artesunate (AS), sulphadoxine-pyrimethamine (SP) and Chloroquine (CQ) in people with Uncomplicated Falciparum Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Pakistan.
Trial summary
This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan. A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Uncomplicated Falciparum Malaria
- What is being tested?
- artesunate (AS), sulphadoxine-pyrimethamine (SP) and Chloroquine (CQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2001to Aug 2006
- Phase
- Phase 2
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- presentation at basic health unit with suspected clinical malaria
- mono-infection infection with P. falciparum confirmed by microscopy
- over 2 years of age (no upper age restriction)
- weight over 5 kg (no upper weight restriction)
- if of child bearing age then non-pregnant and willing to remain so for the duration of the study
- greater than 1 asexual parasite per 10 fields
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- understands and is willing to sign the consent form
- a resident in the study site willing to collaborate for a full period of follow-up
- no signs of severe malaria
Who cannot join
- other serious disease (e.g., cardiac, renal or hepatic)
- in women of child bearing age, pregnancy
- allergy to any of the study drugs or related compounds
- reports to have used any malaria drugs in the last 21 days
- other species of malaria seen
- signs of severe malaria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.
A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.
Read the detailed description
A randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicated falciparum malaria.
Arms:
- CQ
- CQ+primaquine
- CQ+ artesunate
- SP
- SP+primaquine
- SP+artesunate
Patients were allocated to treatment groups using a pseudo-randomised table split by age and sex.
Primary outcomes:
- Clinical and parasitological cure/treatment failure by day 28.
Secondary outcomes:
- time to resolution of fever
- time to clearance of trophozoites
- time to clearance of gametocytes
- gametocyte carriage on or after day 7 after treatment
All clinical assessments and slide readings were carried out by staff blind to treatment arm. Slides were double read.
- Conditions
- Uncomplicated Falciparum Malaria
- Being tested
- artesunate (AS), sulphadoxine-pyrimethamine (SP), Chloroquine (CQ), primaquine (PQ)
- Keywords
- Placebo controlled, Efficacy, Artemisinin-based combination therapy, Primaquine, Gametocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunate (AS)Drug
Recommended dosage over 3 days (for all interventions)
sulphadoxine-pyrimethamine (SP)Drug
Chloroquine (CQ)Drug
primaquine (PQ)Drug
| Study group | Role | What they receive |
|---|---|---|
| CQ | Experimental | Not described Receives: Drug: Chloroquine (CQ) |
| CQ+PQ | Experimental | Not described Receives: Drug: Chloroquine (CQ); Drug: primaquine (PQ) |
| CQ + AS | Experimental | Not described Receives: Drug: artesunate (AS); Drug: Chloroquine (CQ) |
| SP | Experimental | Not described Receives: Drug: sulphadoxine-pyrimethamine (SP) |
| SP + PQ | Experimental | Not described Receives: Drug: sulphadoxine-pyrimethamine (SP); Drug: primaquine (PQ) |
| SP + AS | Experimental | Not described Receives: Drug: artesunate (AS); Drug: sulphadoxine-pyrimethamine (SP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasitological outcome after 28 days follow-up
Measured: 28 days
Secondary outcomes (2)
Asexual parasite clearance by day 7
Measured: 7 days
Gametocyte carriage on or after day 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJul 2001
- Primary completionJun 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated Falciparum 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- HealthNet TPO
- Investigators
- Mark W Rowland, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959517
- Sponsor's protocol ID
- T26/181/33 A00017
- Other IDs
- TDR A00017
- Status last verified
- Aug 2009
- First submitted
- 13 Aug 2009
- Last updated
- 14 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kolaczinski K, Leslie T, Ali I, Durrani N, Lee S, Barends M, Beshir K, Ord R, Hallett R, Rowland M. Defining Plasmodium falciparum treatment in South West Asia: a randomized trial comparing artesunate or primaquine combined with chloroquine or SP. PLoS One. 2012;7(1):e28957. doi: 10.1371/journal.pone.0028957. Epub 2012 Jan 31.
PubMed 22303437
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
- ClinicalTrials.gov ID
- NCT00959517
- Acronym / sponsor ID
- T26/181/33 A00017
- Conditions
- Uncomplicated Falciparum Malaria
- Keywords
- Placebo controlled, Efficacy, Artemisinin-based combination therapy, Primaquine, Gametocytes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- HealthNet TPO
- Study start
- Jul 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 14 Aug 2009 (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.
This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.
A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.
Detailed description
A randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicated falciparum malaria.
Arms:
- CQ
- CQ+primaquine
- CQ+ artesunate
- SP
- SP+primaquine
- SP+artesunate
Patients were allocated to treatment groups using a pseudo-randomised table split by age and sex.
Primary outcomes:
- Clinical and parasitological cure/treatment failure by day 28.
Secondary outcomes:
- time to resolution of fever
- time to clearance of trophozoites
- time to clearance of gametocytes
- gametocyte carriage on or after day 7 after treatment
All clinical assessments and slide readings were carried out by staff blind to treatment arm. Slides were double read.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CQ | Experimental | Drug: Chloroquine (CQ) |
| CQ+PQ | Experimental | Drug: Chloroquine (CQ), Drug: primaquine (PQ) |
| CQ + AS | Experimental | Drug: artesunate (AS), Drug: Chloroquine (CQ) |
| SP | Experimental | Drug: sulphadoxine-pyrimethamine (SP) |
| SP + PQ | Experimental | Drug: sulphadoxine-pyrimethamine (SP), Drug: primaquine (PQ) |
| SP + AS | Experimental | Drug: artesunate (AS), Drug: sulphadoxine-pyrimethamine (SP) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- presentation at basic health unit with suspected clinical malaria
- mono-infection infection with P. falciparum confirmed by microscopy
- over 2 years of age (no upper age restriction)
- weight over 5 kg (no upper weight restriction)
- if of child bearing age then non-pregnant and willing to remain so for the duration of the study
Key exclusion criteria (6 listed)
- other serious disease (e.g., cardiac, renal or hepatic)
- in women of child bearing age, pregnancy
- allergy to any of the study drugs or related compounds
- reports to have used any malaria drugs in the last 21 days
- other species of malaria seen
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 |
|---|---|---|
| artesunate (AS)Recommended dosage over 3 days (for all interventions) | Drug | CQ + AS, SP + AS |
| sulphadoxine-pyrimethamine (SP) | Drug | SP, SP + AS, SP + PQ |
| Chloroquine (CQ) | Drug | CQ, CQ + AS, CQ+PQ |
| primaquine (PQ) | Drug | CQ+PQ, SP + PQ |
Primary outcome
Parasitological outcome after 28 days follow-up
Time frame: 28 days
2 secondary outcomes
Asexual parasite clearance by day 7
Time frame: 7 days
Gametocyte carriage on or after day 7
Time frame: 7 days
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 14 Aug 2009.
- Derived from this study: PubMed 22303437Kolaczinski K, Leslie T, Ali I, Durrani N, Lee S, Barends M, Beshir K, Ord R, Hallett R, Rowland M. Defining Plasmodium falciparum treatment in South West Asia: a randomized trial comparing artesunate or primaquine combined with chloroquine or SP. PLoS One. 2012;7(1):e28957. doi: 10.1371/journal.pone.0028957. Epub 2012 Jan 31.
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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.
Mark W Rowland, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing artesunate (AS), sulphadoxine-pyrimethamine (SP) and Chloroquine (CQ) in people with Uncomplicated Falciparum Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Pakistan.
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 9 inclusion and 6 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 14 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parasitological outcome after 28 days follow-up (time frame: 28 days). 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 NCT00959517, which also lists 1 linked publication.
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 14 Aug 2009.