Malaria, FalciparumPhase 4ECQNWFPNCT01019408
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
A Phase 4 study testing Chloroquine in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 3 sites in Pakistan.
Trial summary
The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy. Read more about this study
- Who is it for?
- Ages 6 months to 60 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Chloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 3 sitesPakistan
- Study dates
- Nov 1993to Jan 1995
- Phase
- Phase 4
- 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 6 months to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- slide-confirmed infection with P. falciparum only
- initial parasite density of 1000-100,000 asexual parasites/μl
- absence of severe malnutrition
- ability to attend stipulated follow-up visits and easy access to facility
- informed consent provided by patient or parent/guardian
- absence of history of hypersensitivity reactions to CQ
Who cannot join
- infants under six months old
- pregnancy or lactation
- underlying chronic severe illness
- patients with other febrile illnesses
- parasitaemia outside the range of 1000-100,000 asexual parasites/µl
- severe malaria
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Adezai Basic Health Unit
Adezai, Khyber Pakhtunkhwa
Baghicha Basic Health Unit
Bāghīcha, Khyber Pakhtunkhwa
Kagan Basic Health Unit
Kagan, Khyber Pakhtunkhwa
About this study
Official title: Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.
Read the detailed description
To determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ 40mg/kg) treatment arms and followed for up to 60 days.
- Conditions
- Malaria, Falciparum
- Being tested
- Chloroquine
- Keywords
- Clinical Trial, Chloroquine, Refugees, Afghanistan, Pakistan
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Also called CQ
Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan
| Study group | Role | What they receive |
|---|---|---|
| CQ25 | Active comparator | Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg. Receives: Drug: Chloroquine |
| CQ40 | Active comparator | Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg. Receives: Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic and parasitological cure with no recrudescence
Measured: 60 days
Secondary outcomes (3)
parasite clearance time
Measured: 28 days
fever clearance time
Measured: 28 days
gametocytaemia
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 1993
- Primary completionJan 1995
- Study completionJan 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, United Nations High Commissioner for Refugees, World Health Organization
- Investigators
- Mark Rowland, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019408
- Sponsor's protocol ID
- NH-HNI01
- Acronym
- ECQNWFP
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
- ClinicalTrials.gov ID
- NCT01019408
- Acronym / sponsor ID
- ECQNWFP / NH-HNI01
- Conditions
- Malaria, Falciparum
- Keywords
- Clinical Trial, Chloroquine, Refugees, Afghanistan, Pakistan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- European Union, United Nations High Commissioner for Refugees, World Health Organization
- Study start
- Nov 1993
- Primary completion
- Jan 1995 (actual)
- Study completion
- Jan 1995 (actual)
- First posted
- 25 Nov 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.
The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.
Detailed description
To determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ 40mg/kg) treatment arms and followed for up to 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CQ25 | Active comparator | Drug: ChloroquineFalciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg. |
| CQ40 | Active comparator | Drug: ChloroquineFalciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg. |
Who may qualify
- Ages
- 6 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- slide-confirmed infection with P. falciparum only
- initial parasite density of 1000-100,000 asexual parasites/μl
- absence of severe malnutrition
- ability to attend stipulated follow-up visits and easy access to facility
- informed consent provided by patient or parent/guardian
Key exclusion criteria (6 listed)
- infants under six months old
- pregnancy or lactation
- underlying chronic severe illness
- patients with other febrile illnesses
- parasitaemia outside the range of 1000-100,000 asexual parasites/µl
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 |
|---|---|---|
| ChloroquineAlso: CQComparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan | Drug | CQ25, CQ40 |
Primary outcome
therapeutic and parasitological cure with no recrudescence
Time frame: 60 days
3 secondary outcomes
parasite clearance time
Time frame: 28 days
fever clearance time
Time frame: 28 days
gametocytaemia
Time frame: 28 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 25 Nov 2009.
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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 Rowland, PhD principal investigator
London School of Hygiene and Tropical Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroquine in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 3 sites 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 6 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 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
therapeutic and parasitological cure with no recrudescence (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2009.